key: cord-0928263-tnwafdr0 authors: Rodríguez‐Huerta, María Dolores; Díez‐Fernández, Ana; Rodríguez‐Alonso, María Jesús; Robles‐González, María; Martín‐Rodríguez, María; González‐García, Alberto title: Nursing care and prevalence of adverse events in prone position: Characteristics of mechanically ventilated patients with severe SARS‐CoV‐2 pulmonary infection date: 2021-03-16 journal: Nurs Crit Care DOI: 10.1111/nicc.12606 sha: 5acc664f909c4c3fb3ab110f00c7272033751605 doc_id: 928263 cord_uid: tnwafdr0 BACKGROUND: Because of the coronavirus disease 2019 (COVID‐19) pandemic, the use of prone positioning has dramatically increased in the intensive care unit (ICU). Because this manoeuvre is related to several complications, it must be performed in a protocolized manner by the appropriate personnel. AIM: To determine the prevalence of adverse events (AEs) in patients admitted to the ICU with a diagnosis of COVID‐19‐related acute respiratory distress syndrome (C‐ARDS) undergoing mechanical ventilation in prone position (PP). DESIGN: Descriptive ambispective study of patients admitted to the ICU diagnosed with C‐ARDS undergoing mechanical ventilation who were in the PP at least once. The number of PP manoeuvres and the time spent in the PP were recorded for each subject. AEs proportions and frequencies were calculated, and analysis of variance was used to assess mean differences in the number of manoeuvres and total hours in PP stratified by the number of facial pressure ulcers. IBM SPSS Statistics v.25.0. and EPIDAT 4.1 software were used. RESULTS: Forty‐four patients were analysed, and 130 PP manoeuvres were performed. The most frequently observed AEs were facial oedema in 26 patients (80.3%) and facial pressure ulcers in 20 (60.6%). There was a significant positive association between the time spent in PP and the development of facial pressure ulcers (P < .001). Enteral nutrition was well tolerated, and no serious AEs or sentinel events were noted. DISCUSSION: Despite the stressful, demanding situation during the peak of the pandemic, the large number of PP manoeuvres, and long duration spent in this position, no serious AEs occurred. This study highlights the need to implement preventive measures to avoid the development of pressure ulcers secondary to prone positioning. RELEVANCE TO PRACTICE: Prone positioning requires a nursing protocol to prevent the occurrence of AEs that may reduce the quality of nursing care. Severe respiratory symptoms caused by the new viral disease coronavirus disease 2019 (COVID- 19) appear after an average period of 5 or 6 days in approximately 20% of the patients, of whom 5% require admission to intensive care units (ICUs) and mechanical ventilation. 1 During the pandemic, ICUs worldwide have been overwhelmingly occupied by patients diagnosed with COVID-19-related acute respiratory distress syndrome (C-ARDS). 2 The overall mortality rate in Spanish ICUs, according to the ELVIN-HELICS registry in 2018, was 9.52%. 3, 4 Since the beginning of the pandemic, this rate has dramatically increased to 20%, highlighting the severity of COVID-19 and the extreme situation in Spanish ICUs during the pandemic. The results of several studies 5, 6 conducted in the last 15 years support the use of the prone position (PP) in conjunction with other interventions, such as lung protective ventilation strategies; therefore, it is currently a highly recommended intervention in ARDS patients. The response may differ from one patient to another, but the PP results in improvements in respiratory mechanics and gas exchange and a decrease in lung heterogeneity, potentially decreasing the risk of the development of ventilation-induced lung injury. 7 Regarding mortality, a systematic review published in 2017 including eight trials comparing prone and supine positions in adults on mechanical ventilation reported a reduction in mortality when PP was used for longer than 12 hours in patients with moderate-tosevere ARDS (PaO 2 /FIO 2 < 200 mm Hg). 8 The World Health Organization (WHO) recommends placing patients with severe C-ARDS (PaO 2 /FIO 2 < 150 mm Hg) undergoing mechanical ventilation in the PP for more than 12 hours per day, provided that sufficient experienced personnel are available to support the safe implementation of the manoeuvre. 9 The Spanish Ministry of Health, following the WHO recommendations during the COVID-19 pandemic, instructed health care professionals to place patients in the PP as soon as possible and to have them remain in that position for at least 16 hours when their PaO 2 /FIO 2 was <150 mm Hg, while providing a high oxygen concentration. 10 Nevertheless, the PP has been associated with the development of potential complications. 11, 12 Recent data from three systematic reviews revealed a significantly increased risk of developing pressure ulcers and endotracheal tube (ETT) obstruction while in the PP than when in the supine position. 8, 11, 13, 14 Adverse events (AEs)-defined as the accidental loss or displacement of invasive devices such as vascular accesses, catheters, or drains; malposition or accidental removal of the ETT; corneal and lingual injuries; vomiting or intolerance of enteral nutrition (EN); and haemodynamic or respiratory destabilization-have been reported. 13, 15 During the COVID-19 pandemic, there has been an important increase in the workload handled by nursing professionals. 16 The use of the PP dramatically increased, offering a unique opportunity to refine and improve clinical protocols, more accurately establish the prevalence of AEs and complications, and elucidate the role of nursing care in the prevention and treatment of such complications. Furthermore, owing to the challenging and complex nature of the position and the inability of the patient to participate in the manoeuvre, at least five health care professionals are needed to place a patient in the PP; therefore, possible areas of improvement in the implementation of this important intervention were also identified. The aim of this study was to determine the prevalence of AEs in patients admitted to the ICU with a diagnosis of C-ARDS undergoing mechanical ventilation in the PP. The secondary aims were (a) to assess the severity of the identified AEs and their consequences; (b) to analyse the procedures and protocols related to the manoeuvre to determine areas for improvement in the nursing care provided to patients in the PP; and (c) to describe the frequency and duration of prone positioning during the COVID-19 pandemic. This is a descriptive ambispective study conducted in the adult ICU of the "La Princesa" University Hospital in the region of Madrid (Spain). Cases from March 6, 2020 (beginning of ICU admissions for this disease), to April 1, 2020 (study inception), were analysed retrospectively, and additional cases were analysed prospectively until May What is known about this topic? • The application of the prone position for at least 12 hours for patients with moderate/severe C-ARDS has been recommended by the WHO and national health agencies. • The prone position in patients undergoing mechanical ventilation is associated with an increased risk of adverse events, especially pressure ulcers and endotracheal tube obstruction. • To prevent adverse effects, a multidisciplinary effort must be made to perform this manoeuvre with the utmost care and safety. What this paper adds? • Despite the high number of pronations and the time spent in that position observed, no serious AEs were recorded in this study and enteral nutrition was generally well tolerated. • A need to improve the protocol for nursing care in these patients was detected, developing a detailed consensus protocol emphasising the use of devices for the prevention of facial pressure ulcers. 31, 2020. This period included the peak incidence of ICU admissions during the pandemic, with the last admission on May 16, 2020. The study concluded once new COVID-19 admissions ceased and when those patients who remained in the ICU did not require further PP manoeuvres. We included consecutive patients admitted to the ICU with a confirmed diagnosis of C-ARDS undergoing mechanical ventilation who placed in the PP at least once during their management in the ICU. The study was approved by the Ethics Committee of "La Princesa" University Hospital, Madrid, Spain (registration number 4105, report 10/20). The need to obtain written informed consent was waived because of the lockdown and the fact that prone positioning was considered part of the routine management of patients with C-ARDS. led to permanent harm, severe temporary harm with an intervention required to sustain life, or death. 18 We also collected demographic and clinical variables, including sex, age, and a previous history of diabetes mellitus, arteriopathy, obesity, and malnutrition. The times between the ICU admission, intubation, and the first PP manoeuvre were calculated in hours. Data were collected until May 31, 2020. As of that date, the individual data collection notebooks were kept in a locked office in the ICU. The PP manoeuvres were medically indicated on a daily basis depending on the patient's status. There was no standardized protocol regarding the specific indication for and duration of each manoeuvre. The need for further PP sessions was determined based on a patient's individual response. For the manoeuvre, an established protocol was followed. The PP team included five members: two physiotherapists, one auxiliary nurse, one assistant to the auxiliary nurse, and one nurse or one intensive care physician at the head of the patient whose role was to control and protect the airway. To prevent pressure ulcers, pressure relief mattresses were used in all beds, hyper-oxygenated fatty acids were applied to protect pressure points, and the patient's arms and head were re-positioned every 2 to 3 hours. In addition, a protective head pillow (Gentle Touch®; Mizuho OSI, California, United States) was used when not contraindicated. Finally, the bed was placed in the anti-Trendelenburg position (8) (9) (10) (11) (12) to avoid gastric regurgitation and prevent bronchial aspiration. The participants' characteristics are presented as the means ± SDs. The principal investigator and five co-investigators (five trained ICU nurses) collected the data from the clinical records and made observations during routine care. To minimize potential information bias that could have led to missed events, commentary records and hospital AE communication records were also reviewed. Of the 106 patients with a confirmed diagnosis of C-ARDS who were admitted to the ICU from March 6, 2020, to May 31, 2020, a total of 44 were included in the study. Of these, 11 were studied retrospectively, which meant that it was not possible to properly record all AEs; therefore, they were included only in the assessment of PP-related variables. Thirty-three patients were included in the analysis of AEs. The flow diagram of the inclusion and exclusion of patients is shown in Figure S1 . The characteristics of the sample are presented in Table 1 The prespecified AEs are presented in Table 2 . Facial oedema was the most common AE, and it was observed in 81.3% of the patients, followed by eye injuries in 12.5%. Other identified AEs were accidental device removal, which occurred in only two patients (6.1%) and one case of ETT obstruction (3.3%). No sentinel events occurred, but four potentially serious events were recorded: haematuria, herpes In the present study, we were able to evaluate the effects of prone positioning in a relatively large number of cases in a short period of time, and most patients underwent multiple PP manoeuvres, each of which lasted many hours. We found that facial oedema and facial pressure ulcers were the most common AEs, whereas EN was gener- Nevertheless, the mortality rate of COVID-19 patients in our ICU was 26.4%, which is slightly lower than the 31% reported in a recent multicentre Spanish study. 19 These figures are even somewhat better than those presented in a recent study that reported that ICU mortality consistently declined from 50% to near 40% as the pandemic prog- F I G U R E 2 Distribution of grade I and II face pressure ulcers in the total sample. Adapted with permission of the author (Arturo Arreola). Available from: https:// tolonet.wordpress.com/category/dibujosa-lapiz/ Furthermore, in our study, 75% of the facial pressure ulcers developed in patients who underwent multiple PP manoeuvres and who remained in the PP for more than 24 consecutive hours. Importantly, all facial pressure ulcers were grade I and II, and there were no detected high-grade ulcers (III and IV). Low-grade facial pressure ulcers have less serious consequences, and none of our patients needed special care or treatment. Once their condition improved and prone positioning was no longer performed, the skin fully recovered in all patients. Interestingly, in previous studies, the procedure for the manoeuvre was similar to that used in our unit, 15 It is important to improve the recording of postural changes of the head, arms, and other supporting points through the use of a checklist. The need to improve the reporting of pressure injuries was also detected. The retrospectively reviewed medical records and nursing charts often failed to adequately report and describe these lesions, perhaps, because they were low grade and healed once the causative factor had been resolved. Finally, as a consequence of the lessons we have learned, we propose to continue observing these events in the future during the normal operation of the ICU with improved recording of the incidence and extent of these events in the nursing charts. With regard to other AEs, the observed incidence of intolerance of nutrition and vomiting (6.1%) was lower than those reported by Gattinoni et al (7.6%) 13 and Taccone et al (29.1%) 26 but higher than that reported by Lucchini et al. 15 In a recent review 27 on nutritional support in critically ill COVID-19 patients, the use of EN was found to be feasible and safe and was not related to an increased risk of gastrointestinal or pulmonary complications. This highlighted the convenience of the post-pyloric placement of a feeding tube in many patients and the importance of an angle of head elevation from 10 to 25 in patients receiving EN while in the PP to decrease the risk of these AEs. 27 The loss of devices occurred only in two patients, no sentinel events occurred, and all four potentially serious events were resolved favourably. One case of ETT obstruction (3.3%) occurred while the patient was in the PP; this is a much lower incidence than those reported in other studies of 50.6% 26 and 4.9%. 28 However, comparisons between AEs among studies should be made with caution because sample sizes and procedures can be varied considerably. In the present study, the lack of serious AEs may be because of the fact that the procedure was always performed with an experienced person (experienced nurse or physician) at the head of the patient who directed the manoeuvre. In addition, precautionary aspiration of endotracheal secretions was performed prior to the manoeuvre. Our study has several limitations that should be acknowledged that could affect the validity and reliability of the results. First, the crosssectional design prevented us from making causal inferences. Second, as mentioned, the recording of postural changes was neither systematic nor comprehensive, which could have resulted in missed events. Even though postural changes were supposed to occur every 2 to 3 hours according to the protocol, they were not recorded by all shifts, making it impossible to determine whether the patients' heads and arms were not moved or the manoeuvres were not recorded. Finally, we could not compare the outcomes of prone and supine positioning because of the conditions during the pandemic. In clinical practice, in order to improve the care and prevention of should be adopted for this specific situation. Our study allows us to conclude that despite the large number of manoeuvres and the long time spent in the PP, no serious AEs occurred, despite the particularly difficult situation at the time. As expected, the longer the time spent in the PP and the greater the number of sessions, the greater the risk of skin lesions. However, owing to the implementation of the usual preventive measures and a protocol that was followed for the manoeuvre, prone positioning did not lead to the development of deep ulcers that required complicated treatments. 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Otolaryngol Head Neck Surg (United States) Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial Nutrition therapy in critically ill patients with coronavirus disease (COVID-19) Prone positioning in severe acute respiratory distress syndrome Nursing care and prevalence of adverse events in prone position: Characteristics of mechanically ventilated patients with severe SARS-CoV-2 pulmonary infection The authors express their gratitude to the ICU nursing staff of "La Princesa" University Hospital for the data collection and, even more important, for their great effort in this complicated and surrealist situ- Data can be available after reasonable request to the authors. Ana Díez-Fernández https://orcid.org/0000-0002-7673-986X