We report the process of implementing a safe, effective way to prone hypoxic patients with minimal materials and without disrupting a system already overwhelmed in a disaster scenario. This is not intended to be an outcome assessment but rather a process evaluation and description of one safe, effective protocol for positional care developed and implemented in a stress induced limited resource setting.
The value of prone positioning in severe ARDS has been supported with class I data since the post hoc analysis of the Prone-Supine group in 20011 but was not widely accepted until the PROSEVA trial reported in 20132. We have had experience with positional therapy for ARDS over many years and in many clinical scenarios5 but at the time of the COVID 19 surge in New York City there was no experience with routine positional care for ARDS in the NYCHHC/Elmhurst Hospital.
NYCHHC/Elmhurst Hospital Center has been described as the “epicenter of the epicenter”6 at the time of the peak in deaths in New York State. At that time, the number of ventilated adult patients in the institution had increased from approximately 30 per day to a maximum of 167 in three weeks’ time. In addition, many staff members became ill, newly improvised critical care units were opened and staff were tasked with an increased level of disease acuity and responsibility, all of which severely stressed the medical system. There were unprecedented shortages of RNs, critical care physicians, RTs, critical care units and ICU beds, laboratory capacity, imaging capacity, medications, CPAP equipment, ventilators, vascular access and dialysis catheters and virtually everything else required for the care of patients with severe lung failure.
Our goal was to provide prone positional therapy in an institution that had never operationalized that aspect of pulmonary critical care before. To do so, especially in a time of volume crisis and situational resource limitation, we sought to proceed with several core principles:
1) The positional therapy must be both safe and demonstrably effective.
2) The process must not require any additional work of the physicians, RNs and RTs involved in the care of the patient.
3) Only readily available materials would be used.
4) Our inclusion criteria and clinical processes would reflect the methods of the Class I data produced from the PROSEVA trial.
5) The program would adhere to principles of HROs.
6) Rigorous adherence to check lists improved continually and in real time and CRM principles would guide all activities from training to practice to evaluations.
7) Intense attention to error in a short loop quality cycle would inform and guide rapid changes and this would be a norm of the team.
8) Concurrent data collection including opportunities for improvement identified in routine post procedure debriefing would inform quality decisions and facilitate protocol transfer.
9) These protocols would be easily adopted by the bedside nurses (RNs) and respiratory therapists (RTs) when the number of critically ill patients returned to a more manageable volume.
Basic principles of HROs and CRM guided the evolution of the program and the culture. These principles enabled the team to implement the primary goals with the speed and safety required under the conditions at NYCHHC/Elmhurst during early April 2020. We purposefully designed and led the evolution of the program with a focus on the five traits of HROs: sensitivity to operations, reluctance to oversimplify the reasons for problems, preoccupation with failure, deference to expertise and resilience.
Specifically, these principles informed our decisions as follows. Sensitivity to operations was evident in the realization that we were functioning in an institution with a high volume of COVID patients with severe ARDS and overwhelmed bedside RNs, RTs, and critical care physicians. The resource limitations in many areas at that time approached those of an austere environment. Reluctance to accept “simple” explanations for problems was a primary motivation for rapid time and point of service debriefings, many short loop correction and re-evaluation cycles and a focus of root causes in the systems domain of error. A preoccupation with failure was best exemplified with a team ethos of an a priori stated concern with “what could possibly go wrong” and a purposefully maintained non punitive flat hierarchy to facilitate criticisms. We also normalized the use of multiple checklists and the simple use of the word “STOP” at any point by any team member. We deferred to expertise whenever possible recognizing that one program leader brought local cultural, academic, clinical pulmonary/medical perspectives, political strength and legitimacy and longevity to the process and the other provided experiential strength with IPP, clinical surgical/ECMO perspectives, program development and performance improvement insights and small team leadership skills. The meticulous attention to detail, discipline, and protocol/de-briefing familiarity of the deployed military team members was an additional asset. Finally, this program was developed and evolved in a dynamic and dangerous environment. Many compromises and great flexibility defined both the scenario and the cultural norms of the team. Resiliency is defined as the “ability to recover from or adjust easily to adversity or change7” and that characteristic is a defining principle of the team. In addition, change was expected and encouraged in rapid sequential quality loops.
The prone team is a cohesive and independent operational team, traits that made it possible to develop rapidly utilizing the principles of CRM. These principles provide a framework for the type of high reliability activity that prone and supine positioning of severely ill and vulnerable patients in a hostile environment characterized by many systems deviations and significant infectious risk to the providers demands. The core principles of CRM that were applicable to this project include a flattened hierarchy, individual and team situational awareness, focus on systems and human errors, non-punitive and immediate feedback, structured communication, crosscheck techniques, and maintaining team integrity and safety.
Our data collection is designed only to assure quality of the intervention and to show that in this setting IPP improves oxygenation as it does with other types of ARDS. In addition, this protocol is applicable in settings where ABGs may not be available by utilizing the pulse oximeter to assess oxygenation. These relationships have been well shown in other populations and they continue to apply under these conditions.
This brief report has several limitations. First, our goal was to produce a process report as quickly as was responsible and valid to assist other medical centers in providing positional therapy for the first time despite situationally limited resources. This project was neither designed nor intended to produce outcome data. Many of the patients were still extremely ill and receiving ongoing care, including prone positioning, at the time we chose to report the series. Second, because we only intended to validate the safety and effectiveness of the process, and to produce a rapid report, we chose to report a case series that was small. Third, our measure of the saturation to inspired oxygen (SaF ratio) utilized the measured SaO2 instead of the observed peripheral pulse oximeter saturation (SpO2). It is a surrogate for an index of oxygenation using only the pulse oximeter (SpF ratio) applicable to more austere settings but, again due to the sheer volume of patients, we were unable to collect those readings with validity. Fourth, our correlation of SaFr with PFr and model fit were only moderately strong and should therefore be interpreted with caution. Moreover, prediction of SaFr based on PFr may not be generalizable to other populations except in concept. Fifth, because we were introducing a seemingly dramatic intervention in an institution that was not familiar with it and that was experiencing multiple extreme stressors, we chose a posture of relative risk aversion regarding patient selection. The one risk we did accept was to position these patients prone with their Hollister ETT holders in place and the ETT in the midline. Under normal conditions this is not advised but we felt that it was necessary. It is preferable to tape the tube and reposition it as indicated and to preform early tracheostomy. At the height of the surge, due to multiple shortages and a temporary moratorium on tracheostomy, which is an aerosol generating procedure, positioning with the tube holder was the only option. With attention to detail in this regard we have not experienced more problems with the prone cohort than in the general intubated population related to that decision. Finally, our selection was limited by our belief that even a focused prone positioning team cannot safely manage more than 15 patients with their 30 positional changes and 45 head turns a day.
Patient safety is a critical endpoint of any medical process and the principles of HROs and CRM are good frameworks to assure the performance of teams in complex and dangerous environments. This is an environment of chaos and hazard characterized by overwhelmed systems, stressed and variously experienced personnel and an infectious agent that is transmitted by aerosol and respiratory droplets from asymptomatic carriers, has no treatment or vaccine and that has a significant infectivity and mortality. Team safety assumes greater dimensions in a truly hazardous environment. Teams, as well as systems, can suffer trauma just like an individual. Effectiveness and excellence in such a time depends on a culture with an unusual focus on safety with a holistic scope. Initiating a program of positional care in the COVID intensive care units (ICUs) at NYCHHC/Elmhurst required meticulous attention to these principles and, although each new situation will require modifications for local conditions, is transferable to other institutions facing similar challenges.
Although COVID 19 causes a type of severe hypoxemic ARDS that responds to positional therapy like other types of lung failure it remains to be seen if patient important outcomes like mortality can be affected. Those conclusions will require a study design and outcomes data not possible with this report’s intentions and time frame. The data reported simply reflect that positional therapy in this scenario increases oxygenation, only modestly and transiently compromises ventilation, can be conducted with readily available materials, including only pulse oximetry, and an acceptable incidence of known complications.