To reduce the incidence of medical device-related pressure injuries associated with tracheostomies performed with the percutaneous dilation technique using a standardized multidisciplinary intervention.
The intervention was developed using the Agency for Healthcare Research and Quality Preventing Pressure Injuries Toolkit. A fenestrated polyurethane foam dressing was sutured in place under the tracheostomy flange during insertion to reduce the risk of medical device-related pressure injuries. The sutures were removed in pairs over a period of 7 to 10 days.
Comparison of data from 2018 to 2021 demonstrated a decrease in the incidence of tracheostomy medical device-related pressure injuries from 13% to 0% in the first year, which was maintained for the following 3 years. This improvement was supported by electronic medical record audits, daily interdisciplinary rounds, weekly practice assessments, and primary nurse evaluations.
Implementation of a standardized process, supported by an interdisciplinary clinical team, can reduce medical device-related pressure injuries among patients undergoing percutaneous dilation tracheostomy.
In the United States, approximately 2.5 million individuals experience hospital-acquired pressure injuries each year, with an approximate cost of $11 billion.1,2 Acute care patients have an increased risk of pressure injuries, as they often require therapeutic interventions to provide support as they navigate their clinical course. The prevalence of pressure injury among adult intensive care unit (ICU) patients is 16.9% to 23.8%, compared with 12% to 18% among general admission patients.3 A medical device-related pressure injury (MDRPI) is a pressure injury resulting from device-related pressure (ie, friction and shear) on the skin, usually conforming to the shape of the device.4 Data from 2017 indicates that MDRPI’s associated with the tracheostomy account for up to 10.9% of hospital-related incidents.5,6
A tracheostomy is an artificial opening in the trachea through which the clinician places a cannula, often made of thermosensitive, polyvinyl chloride.5,7 Tracheostomies facilitate life-saving respiratory support, tracheobronchial toileting, and ventilator weaning, enabling reduced use of sedation.8 Tracheostomies are performed by a surgeon or an intensivist in the ICU using percutaneous dilation. This article focuses on MDRPI prevention for patients undergoing tracheostomy with the percutaneous dilatation technique (PDT) in the ICU. The PDT involves involves insertion of the tracheal cannula through blunt separation of the surrounding tissues.9,10
Skin injuries in tracheostomy patients receiving mechanical ventilation may result from downward pressure of the ventilator tubing, accumulated moisture, proximity of the tracheostomy tube flange to the bony prominences of the clavicles, and immobility of the tracheostomy tube flange when secured by sutures.5,6 These injuries, which conform to the shape and pattern of the tracheostomy tube or ties, are identified as MDRPIs.4 A skin injury that results from the application of a tracheostomy tube, its ties, or related attachments is called a tracheostomy MDRPI. Successful MDRPI reduction and prevention requires a collaborative effort that includes ongoing risk assessment, including skin or soft tissue assessment and protection.11
Current evidence supports the use of pressure-redistributing, absorbent polyurethane foam dressings over body areas in contact with the medical device for prevention of MDRPIs.6 The selected dressing should be included as part of device management, as some devices may be difficult to lift or reposition.4 Research by Cornish12 supported the use of prophylactic dressings as an effective pressure injury prevention modality; further work by Haesler13 described the use of the dressing under the medical device. O’Toole et al6 reported reduction of the incidence of tracheostomy MDRPI with placement of the Lyofoam Max T polyurethane foam dressing (Mölnlycke) in the immediate postoperative period.
Before the intervention described in this article, the standard of care in our ICU involved use of 4 sutures to secure the tracheostomy flange, with nonwoven, fenestrated gauze placed around the flange. The tracheostomy was considered a “new” or “fresh” surgical site for the first 7 days after insertion. The 4 sutures were then removed by day 10. Nurses were primarily responsible for changing the gauze every 12 hours or if it was soiled or loose. The patient would be transferred out of the ICU with the nonwoven gauze dressing in place. Identified cases of tracheostomy MDRPIs in 2 of the PDT tracheostomies drove the process change initiative. The purpose of this multidisciplinary quality improvement project was to reduce the incidence of MDRPIs associated with PDT tracheostomy in an adult ICU in accordance with current evidence.
This project was performed in an 18-bed, mixed-adult ICU in metropolitan New York City. Based on the plan-do-study-act (PDSA) model, it was designed as part of an interdisciplinary, multitiered intervention with the goal of reducing the incidence of tracheostomy MDRPIs. Historically, the PDSA model has been successfully implemented across several manufacturing, engineering, and health-related industries.14 Its structured iterative process with opportunities for reevaluation and learning within the local context supported PDSA as the most suitable model for this project (Figure 1).15
The primary collaborative team for the duration of this project consisted of the clinical nurse specialist (CNS); medical director; cardiothoracic surgeon; Wound, Ostomy and Continence Nursing Certification Board (WOCNCB)-certified nurse; and respiratory therapist. The extended team included 45 registered nurses, 9 ancillary team members, 2 nurse practitioners, and 14 medical intensivists. Medical records were reviewed using the electronic medical record (EMR), with relevant data extracted and recorded in an Excel (Microsoft Corp) spreadsheet.
In the “plan” phase of the PDSA model, the team used the pressure injury prevention pathway in the Agency for Healthcare Research and Quality Preventing Pressure Injuries Toolkit as the primary framework for the intervention, specifically its guidance on planning and implementation to address areas of risk.16 The plan phase consisted of (1) interdisciplinary discussion and subsequent buy-in, (2) acquisition of facility-approved equipment to unit par level, (3) delineation of tasks and role assignment for clinical personnel, and (4) multidisciplinary education for tracheostomy initiation.
The interdisciplinary team gathered initial incidence data from the EMR and assessed current unit practice standards. The WOCNCB-certified nurse proposed use of a commercially available, precut polyurethane dressing beneath the flange as a tracheostomy MDRPI prevention modality.4,13 This dressing would be used for only the first 7 calendar days after tracheostomy placement, after which it would be replaced with the nonwoven gauze dressing. Weekly iterative team meetings were held to engage clinicians, obtain buy-in, and discuss the preliminary tracheostomy intervention process. The final PDT tracheostomy procedural kit document, which was created through a consensus process, was shared with the entire clinical team in December 2018 (Table 1). Printed job aids outlining the procedural tasks and required equipment were distributed to all clinicians.
The lead intensivist and cardiothoracic surgeon provided education to the rest of the medical team. In accordance with the final procedure, the interdisciplinary team participating during the bedside PDT process comprised the intensivist, 2 primary nurses, a nurse practitioner, a charge nurse, and 2 respiratory therapists. Because the standard PDT process often includes pairing the PDT tracheostomy with flexible bronchoscopy, the created job aid included guidance for both the PDT process and bronchoscopy.10 After the bronchoscopy, the cardiothoracic surgeon would place the tracheostomy tube with a Lyofoam Max T polyurethane foam dressing under the flange.13 The tracheostomy tube and Lyofoam Max T dressing were sutured in place using 4 size 0 sutures and additionally secured with a soft, flexible tracheostomy tube holder (Figure 2). The Lyofoam Max T polyurethane foam dressing was scheduled to remain in place at the new PDT site for 7 days.6
In the “do” phase of the PDSA model, the team focused on integrating MDRPI prevention into the bedside PDT procedure. Necessary steps were as follows: (1) verification of patient consent for the procedure, (2) notifying the team of the planned PDT, (3) collection of supplies, (4) equipment testing, and (5) ensuring that resuscitative equipment was on standby. The legacy Shiley tracheostomy tube (Medtronic), Dale tracheostomy tube holder (Dale Medical Products), and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer kits (Cook Medical) were added to the unit’s par of available equipment, and the job aids were attached to the bronchoscope. The bedside PDT procedure with the previous standard of care was a legacy practice in the unit before the arrival of the CNS. The current initiative added both a standardized process and an MDRPI prevention modality to the practice.
After the bedside PDT process, the primary care nurses assessed for exudate, drainage, and bleeding at least every 12 hours, documenting all care in the EMR. The CNS and the WOCNCB-certified nurse also performed real-time clinical audits on all new tracheostomies. Surgical site assessment and any clinician concerns were discussed in daily interdisciplinary rounds. The first pair of lower sutures was removed by the nurse practitioner or intensivist on day 5. The second pair of sutures was removed at 7 to 10 days if there was no evidence of new bleeding, swelling, increase in secretions, or any other clinical indicator of a possible complication in the healing course. The Lyofoam Max T dressing was then changed to the standard nonwoven gauze drain sponge, with subsequent changes every nursing shift or as needed. Nursing assessments were completed and documented every 12 hours according to the current standard of care.
Study and Act Phases
The “study” phase consisted of the following steps: (1) team practice evaluation during the PDT process and (2) clinical audits of the EMR. Reports on the incidence of percutaneous tracheostomy and MDRPI were readily available from the EMR. The incidence of PDT tracheostomy was audited in real time at 3-, 6-, and 9-month intervals by the CNS in collaboration with the WOCNCB-certified nurse, the primary care nurse, and the intensivist. Daily multidisciplinary rounding by the clinical team is a standard practice and remains in place. Any changes in surgical site assessment (eg, bleeding, loose sutures, or altered skin integrity) were escalated to the medical team, who provided either care recommendations or educational support. Daily shift huddles at the beginning of each nursing shift, during which the status of current or pending tracheostomies as well as other patient events were shared and reported, were part of the “act” phase. Primary nurses’ feedback on procedural utility and practice standardization was used to help determine whether the intervention needed to be adapted. Subsequent tracheostomy tube insertions were also followed up using retrospective medical record review with an option to use PDSA cycles for any evolving concerns.
Updated Process Due to COVID-19 Challenges
In 2020, with the advent of COVID-19 and the worldwide demand for health care equipment, our new process was affected by challenges related to product availability and consistency.17 The product used in the initial implementation was no longer readily available from the manufacturer; therefore, the multidisciplinary team started a new PDSA cycle. In the new “plan” phase, the ICU procedural job aid was updated to include the tracheostomy introducer set (Table 2). In the new “do” phase, the new consensus document was communicated via email to all clinicians by nursing leadership. The 2018 procedural list and job aid were transitioned to include the new PDT tracheostomy introducer set and flexible Shiley tracheostomy tube. Communication with the primary care team was performed via email as well as unit-based meetings. In the new “study” phase, the primary care nurses, CNS, and WOCNCB-certified nurse restarted the clinical audits to maintain the integrity of the new process and current patient outcomes. All planned tracheostomies were reviewed with the primary care nurses, intensivists, and surgeon to facilitate standardization of the new process. The new “act” phase centered on daily multidisciplinary rounds with options to reevaluate the current process as supplies and equipment changes evolved.
The primary outcome measure was the prevention of tracheostomy MDRPI secondary to a bedside PDT tracheostomy in the ICU. Analysis of retrospective data was performed using simple charts to reflect change in incidence over time (Figure 3). In 2018, the incidence of hospital-acquired pressure injury (HAPI) was 1.39% for all ICU patients, with tracheostomy MDRPIs accounting for 0.19% of the incidents (15 unit-acquired HAPIs including 2 MDRPIs in 1077 patients). However, of the 2 percutaneous tracheostomies performed, both patients experienced MDRPIs. In 2019, the overall HAPI incidence decreased to 1.30%, with 9 percutaneous tracheostomies and no MDRPIs (15 unit-acquired HAPIs in 1155 patients). The tracheostomy MDRPI incidence remained at zero for 2020, 2021, and 2022 as of the current date. In the 4 years of this initiative, we found a total tracheostomy MDRPI incidence of 6.67% (30 unit-acquired HAPIs including 2 MDRPIs).
During the 4 years of this project, a total of 22 percutaneous tracheostomies were performed in the ICU. The polyurethane foam dressing was placed at the point of insertion in all procedures. More than half of the clinicians (intensivists, primary care nurses, respiratory therapists, and ancillary team members) who made up the clinical staff in 2018 were still part of the staff in 2021. Even with the adaptation of the intervention in 2020, tracheostomy MDRPIs in the ICU remained at zero.
This quality improvement project resulted in a reduction of the incidence of tracheostomy MDRPIs to zero in 2019, with no increase observed over the next 3 years. Thus, this project brought about a sustained practice change through its multidisciplinary approach and standardized process, including clinical audits, primary care nurse engagement, EMR audits, and clear communication. The project showed suturing of a polyurethane foam dressing at the time of PDT tracheostomy insertion to be an effective therapeutic intervention to prevent tracheostomy MDRPIs.18 The increasing volume of PDT tracheostomies performed over time, the multidisciplinary approach, and the stable team of practitioners all contributed to the success of this initiative.19,20
In 2018, Dixon et al21 performed a study examining timed suture removal and use of a polyurethane foam dressing after suture removal as part of the tracheostomy MDRPI bundle. They noted an 80% reduction in MDRPIs over a 7-month period. Similarly, O’Toole et al6 expressed support for the implementation of a standardized posttracheostomy care bundle. However, that study, involving medical surgical units, the operating room, and the ICU, involved use of a hydrocolloid dressing in the immediate postoperative period with suture removal at 7 days and placement of a polyurethane foam dressing after suture removal. Carroll et al,22 after implementation of a multidisciplinary perioperative protocol, also noted a decrease in the incidence of tracheostomy MDRPIs to zero; this study involved initial placement of a hydrocolloid dressing that was replaced with a hydrophilic foam dressing 3 days after insertion. These studies provide evidence that aligns with our chosen methodological process and outcomes.
Strengths and Limitations
Our initiative provided a clear process for the bedside percutaneous tracheostomy procedure and tracheostomy MDRPI prevention interventions, which became an established clinical process in the ICU. The success of this initiative has resulted in clinical practice and policy changes, influencing all hospitals in the system. The LyofoamMax T polyurethane foam dressing as an initial dressing for PDT tracheostomies, suture placement, and subsequent removal has been adopted as a standard of care for prevention of tracheostomy MDRPIs. It should be noted that this project was conducted in tandem with another unit-based program, guided by the Agency for Healthcare Research and Quality Preventing Pressure Injuries Toolkit, to address the overall rate of unit-acquired HAPIs. We speculate that this increased overall vigilance benefited our efforts.
This quality improvement initiative was limited primarily by its location and sample population. All procedures were planned and implemented in a closed adult ICU when the patient was clinically stable, excluding the operating room and the pediatric population. Emergency surgical tracheostomies were not included in this initiative as they often result from an immediate airway compromise and precede escalation of live-saving interventions. Although the multidisciplinary team evaluated the EMR, in conjunction with real-time clinical audits, a larger sample size might pose a challenge to this implementation method.
This quality improvement initiative demonstrated that placement of a polyurethane foam dressing at the point of insertion during percutaneous dilation tracheostomy can reduce the incidence of tracheostomy MDRPIs. These findings depend on the engagement of all related specialties, nursing education, and an EMR to recover data. Although some process modifications may be necessary, the protective elements of the polyurethane foam dressing may benefit other patient populations as well, including pediatric, neonatal, and surgical. Overall, the results of this project add to the existing evidence that prevention of tracheostomy MDRPI is a viable strategy for improving patient outcomes.
We thank Laurie Walsh, dnp, rn, for her operational support and guidance and Hilary Poff, msn, rn, cwocn, for her clinical expertise and practice support.
The authors declare no conflicts of interest. The contents of this article do not necessarily represent the views of New York Presbyterian Hospital.