Association of Standardized Tracheostomy Care Protocol Implementation and Reinforcement With the Prevention of Life-Threatening Respiratory Events | Critical Care Medicine | JAMA Otolaryngology–Head & Neck Surgery | JAMA Network
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Table 1.  Patient Demographics and Indications for Tracheostomy Placement
Patient Demographics and Indications for Tracheostomy Placement
Table 2.  Rapid Responses Before and After Tracheostomy Protocol Implementation
Rapid Responses Before and After Tracheostomy Protocol Implementation
Table 3.  Time Spent in Each Hospital Unit Based on Location and Rapid Response Event
Time Spent in Each Hospital Unit Based on Location and Rapid Response Event
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Original Investigation
June 2018

Association of Standardized Tracheostomy Care Protocol Implementation and Reinforcement With the Prevention of Life-Threatening Respiratory Events

Author Affiliations
  • 1Department of Otolaryngology–Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill
  • 2Department of Respiratory Therapy, University of North Carolina School of Medicine, Chapel Hill
JAMA Otolaryngol Head Neck Surg. 2018;144(6):527-532. doi:10.1001/jamaoto.2018.0484
Key Points

Question  What is the effect of implementation of a tracheostomy care protocol on the occurrence of life-threatening respiratory compromise?

Findings  A cohort study of 247 patients (117 preprotocol and 130 postprotocol) who received tracheostomy was conducted. More patients in the preprotocol group experienced a mucus plugging rapid response than in the postprotocol group, showing a reduction of mucus plugging events after protocol implementation.

Meaning  Implementation of a standardized tracheostomy care guideline was associated with the reduction in the occurrence of life-threatening respiratory compromise.

Abstract

Importance  Mucus plugging after tracheostomy is a preventable cause of respiratory distress. Implementation of standardized tracheostomy care guidelines may reduce the occurrence of fatal respiratory compromise.

Objective  To determine the effect of implementing and reinforcing a standardized tracheostomy care protocol on the occurrence of acute life-threatening respiratory events.

Design, Setting, and Participants  Retrospective cohort study of adult patients who received a tracheostomy between May 2014 and August 2016 at a tertiary care center.

Main Outcomes and Measures  Patient demographics, tracheostomy indication, rapid response for mucus plugging and other acute events, duration of hospital stay, and levels of care that the patients received were recorded through examination of clinical logs. Statistical analysis was conducted between patients before protocol implementation and patients after protocol implementation in terms of rapid-response use, and intragroup comparison of the mean length of stay in various hospital units was also analyzed.

Results  A total of 247 patients (89 women [36%]; mean [SD] age, 58.5 [12.3] years), 117 preprotocol and 130 postprotocol, met inclusion criteria. Of the 130 patients in the postprotocol cohort, 123 (93%) were on the new tracheostomy care protocol. Preprotocol rapid-response rate was 21 of 117 patients (17.9%) and postprotocol response rate was 12 of 130 patients (9.2%) for a difference of 8.7% (95% CI, 0.2%-18.0%). In terms of mucus plugging, preprotocol rate was 8 of 117 patients (6.8%) and the postprotocol rate was 1 of 130 patients (0.8%) for a difference of 6.0% (95% CI, 1.3%-12.2%). Intragroup difference of the mean time spent (days) in various care units between patients in the no rapid-response group vs rapid-response group demonstrated clinically meaningful longer stay for rapid responses in both preprotocol and postprotocol groups for the intensive care unit (preprotocol, 2.03; 95% CI, 1.03-3.03 vs postprotocol, 3.02; 95% CI, 1.49-4.45) and step down units (preprotocol, 1.40; 95% CI, 0.77-2.02 vs postprotocol, 2.11; 95% CI, 0.78 to 3.44).

Conclusions and Relevance  Implementation and reinforcement of a standardized tracheostomy care protocol was associated with a reduction in the occurrences of rapid-response calls for life-threatening mucus plugging and is recommended for clinical practice. In addition, length of stay in the intensive care unit and intermediate surgical care unit was increased in a clinically meaningful way for patients who experienced a rapid-response event.

Introduction

Tracheostomies are performed for a variety of reasons, including major surgical operations of the head and neck, airway obstructions, prolonged intubation, and aspiration.1,2 While a tracheostomy provides the patient secure access to the airway, without proper care, the tracheostomy tube can become obstructed from secretions leading to emergent airway distress.3 Obstruction of a tracheostomy tube with mucus plugging is a known preventable complication that results in rapid respiratory distress. In the hospital setting, this leads to rapid-response calls, escalation in the levels of care, and if not cleared, death from asphyxiation. It is therefore critical the tracheostomy tube remain patent to ensure safe respiration and patient convalescence.

Tracheostomy alters the natural airway lining and therefore can make the patient more vulnerable to mucus plugging caused by hypersecretion of the cell linings.4 Untreated mucus plugging may become rapidly fatal. To reduce the occurrence of mucus obstruction, tracheostomy care with saline flushes and suctioning remains a common practice in the hospital setting.5 While no particular consensus exists as to exact frequency of suctioning for those with tracheostomies, generally it is accepted that the tracheostomy tube inner cannula be removed twice daily for cleaning and the patient otherwise receive frequent saline lavage and suctioning in between with a frequency at the discretion of the physician.6 In the first few days after placement of the tracheostomy tube it is also recognized in the surgical literature that patient secretions are typically more copious and thus require more frequent attention.5

Emergency airway control poses a serious challenge for physicians in the hospital setting. Many health care institutions have adopted the practice of creating a specialized team to evaluate and treat patients that have serious complications, including airway compromise.7-10 Our institution has rapid-response teams that respond when called on by a member of the staff taking care of the patient. Ideally, proper management and care of the patient with a recent tracheostomy would reduce the chances of respiratory events and thus secondarily reduce the occurrence of these rapid-response team calls for life-threatening mucus plugging. In addition, avoidance of these preventable events reduces the physical and psychological stress to the patient and thereby improves the quality and safety of care.

While the importance of tracheostomy care is common knowledge among otolaryngologists and respiratory therapists, such knowledge is not a pervasive within other medical disciplines, nursing staff, or ancillary providers. The senior author (T.H.) recognized a series of patients in our institution who had suffered from life-threatening mucus plugging within days following tracheostomy. Upon investigation of these cases by the surgeon and senior respiratory therapist, they uncovered a significant knowledge gap among the nursing staff on the floor and intensive care units, as well as nonotolaryngology physicians, with respect to appropriate tracheostomy care. While education across all health care professionals can address specific knowledge gaps and should be performed, to ensure patient safety, standardized care protocols are an excellent tool because they provide a concrete structure and reference for all health care professionals for a variety of situations.

The objective of this study was to examine whether implementation of a postoperative tracheostomy care protocol would reduce the occurrence of life-threatening mucus plugging, as assessed by the occurrence of rapid-response calls. In addition, we aimed to examine how prevention of this sentinel event and the use of rapid-response calls could influence the duration and quality of care patients receive during their stay in the hospital.

Methods

The institutional review board of the University of North Carolina granted exemption for this retrospective cohort quality improvement study. Clinical logs were requested of adult patients who underwent fresh surgical airways from May 2014 to August 2016; written informed consent was not required because patient records were deidentified.

Tracheostomy Care Root Cause Analysis and Assessment

A multidisciplinary collaborative airway task force of otolaryngology surgeons, nurse practitioners, and a senior respiratory therapist was formed to investigate the respiratory events in patients following tracheostomy. A root-cause analysis of these cases revealed a lack of clear orders on some patients, but also that despite active orders for “routine tracheostomy care,” including tracheostomy tube cleanings twice daily and saline lavage and suctioning every 2 to 4 hours as needed in other patients, there was lack of adherence to the orders by the floor staff, as well as uncertainty to proper tracheostomy care by the staff. Clearly, there was a significant patient safety issue due to both inconsistent and unclear orders by the primary team, as well as significant knowledge gap among providers caring for patients with tracheostomies.

Protocol Development

In response to the results of the root cause analysis, the task force determined 2 objectives: (1) to design a clear standardized posttracheostomy care protocol, and (2) to develop an implementation plan to maximize adherence of the protocol by all hospital personnel. The task force developed an agreed upon current “best practice” guidelines for care of postoperative tracheostomy patients based upon their years of expertise in the management of these patients (Box).

Box Section Ref ID
Box.

Postoperative Tracheostomy Suctioning Policy

  • Suctioning policy applies to all patients undergoing laryngectomy and tracheostomy.

    • All additional care will be directed by the otolaryngologist who performed the original laryngectomy and/or tracheostomy or by the surgeon’s designee.

  • Protocol guideline

    • First 24 hours postsurgery: Patients who received laryngectomy and/or tracheostomy will be suctioned every 2 hours (and as needed) with 3 to 5 cc normal saline with a sterile bullet.

    • 24 to 48 Hours postsurgery: Patients will be suctioned every 4 hours (and as needed) unless otherwise directed by an otolaryngologist.

    • More than 48 hours postsurgery: Patients will still require suction every 2 hours, every 4 hours, and/or as needed as directed by the otolaryngologist or secretion production.

  • All staff associated with care of patients who received tracheostomy and/or laryngectomy will be trained on proper suctioning.

  • Suctioning is to be performed on a 24-hour basis; patients who are sleeping will need to be awakened for suctioning and airway inspection purposes.

Protocol Implementation

Over a period of 4 months, the senior respiratory therapist met with each individual patient care unit within the hospital and educated the nursing, respiratory therapy, and house staff about the tracheostomy protocol. The background for protocol development, the patient safety consequences of improper tracheostomy care, the content of the protocol, and the location of the protocol within the electronic health record and on the hospital intranet were all reviewed with the hospital floors. Hard copies of the protocol were also posted in every care unit with contact information of the task force members, and a champion was nominated for each unit. The senior surgeon (T.H.) championed education of the otolaryngology and surgical house staff as to presence of the new protocol and the importance of compliance with using the order set within the electronic health record on all patients. Following the initial implementation and education, the senior respiratory therapist then performed quarterly inservice review of the unit compliance with the protocol, including a brief meeting with the unit champion and the staff.

Clinical Data

Medical records of adult patients (>18 years of age) who had a tracheostomy placement before the implementation of a standardized suctioning protocol (Box) from May 2014 to April 2015 were examined. After allowing for a 4-month period (May 2015 to August 2015) for protocol implementation, patients from September 2015 to August 2016 (postprotocol) were examined. Rapid-response calls, which are identifiable documented events in the medical record, were used as a surrogate to identify significant potentially life-threatening events. Each patient’s medical record was examined for patient demographics (age, sex), the indication for tracheostomy (4 categories: planned surgery, airway obstruction, prolonged intubation, and aspiration). Planned surgery indicated tracheostomy performed in conjunction with head and neck procedures; airway obstruction, tracheostomy for airway compromise from mechanical obstruction; prolonged intubation, patients requiring prolonged ventilation; and aspiration, patients with acute airway compromise due to aspiration. In addition, the presence of tracheostomy care orders, rapid-response calls, length of stay in the intensive care unit (ICU), intermediate surgical care unit (ISCU), and floor, and increases in level of care (floor to ISCU, floor to ICU, or ISCU to ICU) were all also recorded to conduct the investigation.

Outcomes and Statistical Analysis

Outcomes of interests between the preprotocol and postprotocol periods included frequency of overall rapid-response calls, rapid-response calls for mucus plugging, length of stay in each hospital unit, and need for increased level of care. Effect size measures and 95% CIs around the effect size measures were included to provided readers with estimates of the precision of observed effect size and whether the data are compatible with clinically meaningful differences. Bivariate testing was performed using χ2 tests for categorical variables, and Student t tests and Mann-Whitney U tests for normally and nonnormally distributed continuous variables, respectively. All statistical analyses were performed using STATA/IC 15.0 software (Stata Corporation).

Results

A total of 247 patients, 117 preprotocol and 130 postprotocol, were part of the study. Of the 130 postprotocol implementation patients, 123 (93%) were on the new tracheostomy care protocol. Patient demographics and surgical causes are outlined in Table 1. There was no significant difference between the preprotocol and postprotocol groups in terms of sex, age, or surgical indication for tracheostomy.

The use of rapid-response team calls were found in both groups. Table 2 summarizes the data obtained from total rapid-response calls during the specified study time frame. Preprotocol rapid-response rate was 21 of 117 cases (17.9%), and postprotocol response rate was 12 of 130 cases (9.2%) for a difference of 8.7% (95% CI, 0.2%-18%). In terms of mucus plugging, preprotocol rate was 8 of 117 cases (6.8%), and the postprotocol rate was 1 of 12 cases (0.8%) for a difference of 6.0% (95% CI, 1.3%-12.2%). The 1 patient in the postprotocol group that experienced a mucus plugging rapid-response team call was 1 of the 7 patients not on the proper tracheostomy suctioning protocol.

In the preprotocol group, a total of 21 rapid responses were called: 18 (85%) occurring on the floor, 1 (5%) in the ISCU, and 2 (10%) in the ICU. Of the 8 mucus plugging events, 7 (88%) occurred on the floor and 1 (12%) in the ICU. In the postprotocol group, a total of 12 rapid responses occurred, with 9 (75%) on the floor, 3 (25%) in the ISCU, and none in the ICU. The sole mucus plugging event occurred on the floor.

Level-of-care changes consisted of unit changes of either floor to ISCU, floor to ICU, or ISCU to ICU. In the preprotocol group, 7 level changes occurred with rapid responses with 4 (57.1%) of them due to mucus plugging. In the postprotocol group, there were 3 total level-of-care changes, with none of them due to mucus plugging.

Three hospital locations (ICU, ISCU, and the floor) were of interest, and mean length of stay (days) in each unit was calculated. Data were stratified based on whether the patients had a rapid-response event within the preprotocol and postprotocol group (Table 3). The difference in mean of length of stay for each unit was also calculated within the preprotocol and postprotocol group. The difference in mean length of stay was determined by taking the mean length of stay of the rapid-response group and subtracting it by the mean length of stay in the no rapid-response group.

In the preprotocol group, the difference in mean length of stay (days) between the no rapid-response group and rapid-response group was 2.03 (95% CI, 1.03 to 3.03) for the ICU; 1.40 (95% CI, 0.77 to 2.02) for the ISCU; and 1.89 (95% CI, −1.09 to 4.87) for the floor. In the postprotocol group, the difference in mean length of stay (days) between the no rapid-response group and rapid-response group was 3.02 (95% CI, 1.49 to 4.54) for the ICU; 2.11 (95% CI, 0.78 to 3.44) for the ISCU; and 2.89 (95% CI, 0.53 to 5.25) for the floor.

Discussion

Our study demonstrated that after the careful creation and thorough implementation of our tracheostomy care protocol, including hands-on staff education as to the importance of the policy, there was an associated clinically meaningful reduction in the occurrence of mucus plugging acute respiratory emergencies. Paramount to the success of the study was the 93% penetrance of protocol adoption, which we credit to the continued vigilance of the senior respiratory therapist as a champion of the initiative during the 4-month implementation and the year following. In addition, we believe creation of unit-based champions strengthened the initiative.

Airway obstruction after tracheostomy is a preventable complication which can rapidly progress resulting in significant morbidity and potential mortality. Tracheostomy complications remain a cause of acute medical emergencies requiring a specialized team to intervene in immediate care.11 Many hospitals have developed methods to teach various health care providers how to care for patients who received tracheostomy with a variety of resources.12,13 Suctioning care prevents the development of mucus obstruction. However, standardized guidelines for tracheostomy suctioning do not exist, and the policies vary between institutions.

Seeing the need to improve patient safety, our team sought to create a standardized protocol as outlined in the Box, thereby reducing the occurrence of acute airway emergencies on patients following tracheostomy. Mucus plugging remains a dangerous event in patients who received tracheostomy that can cause fatal respiratory compromise.14 Frequent and scheduled suctioning is a critical aspect to maintain a patent and viable airway for patients who received tracheostomy.6

There was no additional quantifiable cost to the development of our protocol. The success of our protocol is credited to all those involved in development and implementation. These members saw the necessity of improving patient quality of care and voluntarily chose to lead, develop, and implement a hospital-wide protocol without any compensation or incentive.

We strongly believe reducing these events not only improves the care, outcomes, and quality of life of for our patients, but also the quality of life for the physicians. The up-front work decreases downstream resource utilization (less code team activations, family discussions, phases-of-care escalations). Therefore, an important aspect to the success of our quality improvement study is the selfless teamwork and collaborative effort by all those involved.

A care protocol is only effective when used, and the diligence applied to hospital-wide education inservices on this protocol was critical to its success. Despite the high rate of protocol adoption, the signal event in the postprotocol group was on a patient not placed on the protocol. This further underscores not only the importance and efficacy of a standardized protocol for airway management, but the continued diligence required to ensure universal adoption. One could argue that had we had full penetrance of the protocol for the patients after policy implementation, the single adverse event may have been prevented. Regardless, the occurrence of the mucus plugging declined, reducing overall morbidity and potential mortality, as well as hospital resource utilization in the postprotocol group.

Our study did have a 7% failure rate of patients being on the new protocol. A potential explanation for this is the constant change of the staff taking care of these patients. Within a large tertiary care center, the staff in charge of patients who received tracheostomy does turn over, and therefore those that did not have proper exposure and education of the protocol will constantly enter the system. This barrier is being addressed by appointing floor “champions” who can continue to provide education and compliance with this protocol.

Airway management teams are composed of members within various specialties that fulfill a specialized role to increase efficacy of care.15,16 Ideally, prevention of acute airway obstructions would reduce the need of airway emergencies calls. Despite the use of rapid-response teams for management, ineffective treatment, increased level of care, and patient morality are all potential consequences in these acute emergency events.8 Our study was aimed at this objective of reducing the need of rapid-response team calls with a focus on obstruction from mucus plugging in patients following recent tracheostomy. We were able to see a reduction in the occurrence of both overall rapid responses and mucus plugging rapid responses. Effectively, by reducing the occurrence of mucus plugging, we also meaningfully saw a reduction in the overall rapid-response call rate.

Hospital stays and the unit in which the patient receives care can influence the treatment received, patient morbidity, and overall cost. In our cohort, the time spent in the various units of the hospital after tracheostomy was directly influenced by the use of rapid-response calls. Our results demonstrate that a rapid-response call, of any etiology, was associated with a longer ICU and ISCU length of stay in both the preprotocol and postprotocol groups owing to unplanned emergent “bounce back” transfers to the unit.

Increased utilization of monitored units implies a greater risk of patient morbidity resulting in the need for more monitored care or treatment.17-21 Beyond the patient safety and quality-of-care benefits of reduced morbidity and mortality found with implementation of our respiratory care protocol, there is also patient financial and institutional benefits to reducing the need for higher resource intensive beds. At our institution, the facility charger per day of an ICU bed ($5340), or stepdown (ISCU) bed ($3585) is significantly more than that of a surgical floor bed ($1800), which can dramatically affect the overall charges accumulated for a patient admission. While charges are not equivalent to the actual costs incurred, they are more readily available, and therefore, we used them as surrogate to demonstrate possible financial disparity between phases of care. In addition, by reducing the utilization of ICU and ISCU beds, this protocol in essence increased “virtual bed space” in the units to accommodate other patients in need of a more resource-intensive care setting.22-24

With intensive care bed space at a premium, our institution aims to reduce the unnecessary utilization of ICU and ISCU care after tracheostomy, so as to keep these beds available for management of complex surgical patients at our facility. A transfer of care to the ICU directly indicates patient compromise with a higher rate of increased complications in these units.25 Our results indicate that the there was clinically meaningful increase in time spent in the ICU or ISCU in both the preprotocol and postprotocol group for rapid-response calls. Therefore, the suctioning policy, which may reduce the occurrence of rapid-response calls, may indirectly reduce the times spent in these higher level of care units by preventing readmissions to these unit from the floor. Beyond prevention of respiratory events, minimization of patient transfer toward higher levels of care was a secondary benefit of implementation of our tracheostomy care policy.

Additionally, analyzing results from a patient perspective is critical to determining the impact of quality of care improvement. While the most important factor to assess is the reduction in potential morbidity and mortality, another important factor is the financial burden on patients with the high cost of health care. Intensive care unit or ISCU care involves a substantially higher cost than care in the general floor of a hospital.26 Efforts to minimize the need of intensive care would optimize both cost on the patient and efficiency of medical treatment. In addition, longer stays in the ICU may result in more profound physical and psychological deconditioning, which delay return to normal functional status.27-30

Finally, while not captured in this study, the inherent emotional and psychological stress experienced by a patient undergoing a rapid response for an adverse event should not be discounted.31 The events are often frightening and disorienting for patients. This coupled with the perceived “setback” of transfer to a monitored bed, along with the future fear of another potential life-threatening event, can severely effect a patient’s emotional and psychological state, delaying their holistic recovery to their pretreatment state.

Limitations

Our study was limited by the fact that it was a single institutional experience and required retrospective analysis of our institutional database. Therefore, we are limited by what is documented. All respiratory and other patient emergency events at our institution require the calling of a rapid-response “code” team and proper documentation by the hospital personnel. Despite this, missed events are possible and an inherent limitation of our study method. We utilized a hospital database, and we are also limited by what is recorded in this database. Nevertheless, the groups compared in this study were pulled from the same institutional database by an independent third-party hospital administrator to minimize bias between the groups.

Conclusions

Our study demonstrates that implementation of a suctioning guideline for tracheostomy care in the hospital setting is associated with a clinically meaningful reduction in the occurrence of acute rapid-response calls due to respiratory compromise. Successful implementation required not only generation of a standardized protocol, but also continued surveillance of the various units and their compliance. In addition, the time spent in ICUs were increased in a clinically meaningful way with rapid-response calls in both groups, underscoring that effective reduction of rapid responses can reduce overall stays in ICUs. Building on the framework of this study, future studies are planned to perform root cause analysis of other causes for rapid responses and potentially develop additional protocols to address these significant events.

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Article Information

Corresponding Author: Trevor G. Hackman, MD, University of North Carolina at Chapel Hill School of Medicine, Department of Otolaryngology–Head and Neck Surgery, 170 Manning Dr, Campus Box #7070, Chapel Hill, NC 27599 (trevor_hackman@med.unc.edu).

Accepted for Publication: March 15, 2018.

Correction: This article was corrected on June 21, 2018, for errors in the description of suction required by patients in the Box.

Published Online: May 24, 2018. doi:10.1001/jamaoto.2018.0484

Author Contributions: Dr Hackman had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Masood, Hackman.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Masood, Biancaniello, Hackman.

Critical revision of the manuscript for important intellectual content: Masood, Farquhar, Hackman.

Statistical analysis: Masood, Farquhar.

Administrative, technical, or material support: Masood, Biancaniello, Hackman.

Study supervision: Farquhar, Hackman.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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