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Research Letter May 15, 2020

Use of Prone Positioning in Nonintubated Patients With COVID-19 and Hypoxemic Acute Respiratory Failure

Xavier Elharrar, Youssef Trigui, Anne-Marie Dols, et al

JAMA. Published online May 15, 2020. doi:10.1001/jama.2020.8255

Patients with coronavirus disease 2019 (COVID-19) are at risk for acute respiratory distress syndrome.1 In intubated patients with severe acute respiratory distress syndrome, early and prolonged (at least 12 hours daily) prone positioning (PP) improves oxygenation and decreases mortality.2,3 Because intensive care units (ICUs) are overloaded with patients with COVID-19, awake PP may be useful to improve oxygenation and prevent ICU transfers.4 The objective of the study was to evaluate the feasibility, efficacy, and tolerance of PP in awake patients with COVID-19 hospitalized outside the ICU.

Methods

This prospective, single-center, before-after study was conducted among awake, nonintubated, spontaneously breathing patients with COVID-19 and hypoxemic acute respiratory failure requiring oxygen supplementation. The patients were admitted to Aix-en-Provence Hospital (France) from March 27 to April 8, 2020.

All consecutive patients with confirmed COVID-19 were screened and considered eligible if they (1) required oxygen supplementation and (2) had chest computed tomography findings suggestive of COVID-19 with posterior lesions. The main exclusion criteria were acute respiratory failure requiring intubation and impaired consciousness. The same oxygen supply (device and fraction of inspired oxygen) was maintained during the study. Arterial blood gases were performed just before PP, during PP, and 6 to 12 hours after resupination.

The main outcome was the proportion of responders (partial pressure of arterial oxygen [Pao2] increase ≥20% between before and during PP). Secondary outcomes included Pao2 and partial pressure of arterial carbon dioxide (Paco2) variation (difference in Pao2 or Paco2 between before and during PP or after resupination), feasibility (proportion of patients sustaining PP ≥1 hour and ≥3 hours), and proportion of persistent responders (Pao2 increase ≥20% between before PP and after resupination). Tolerance was monitored with 10-cm visual analog scales for dyspnea and discomfort, anchored with no breathlessness or discomfort at 0 cm and maximum possible breathlessness or discomfort at 10 cm. Adverse events were monitored.

Patients were followed up for 10 days until April 18, 2020. Institutional review board approval was obtained. Written informed consent from patients was required.

Variations of Pao2 were compared using a Wilcoxon signed-rank test for patients tolerating PP for 3 hours or more with a P < .01 (2-sided) to adjust for test multiplicity. Analyses were conducted using Stata version 14.0 (StataCorp).

Results

A total of 88 patients with COVID-19 were admitted during the period. Sixty-three patients did not meet inclusion criteria. Among the 25 eligible, 24 agreed to participate; of those, 4 (17%) did not tolerate PP for more than 1 hour, 5 (21%) tolerated it for 1 to 3 hours, and 15 (63%) tolerated it for more than 3 hours. Characteristics of the patients and main results are displayed in the Table. The median time from admission to first PP was 1 day (interquartile range, 0-1.5). Neither sedation nor anxiolytics were used.

Six patients were responders to PP, representing 25% (95% CI, 12%-45%) of the 24 patients included and representing 40% (6/15) (95% CI, 20%-64%) of the patients who sustained PP for 3 hours or more. Three patients were persistent responders. Among patients who sustained PP for 3 hours or more, Pao2 increased from a mean (SD) of 73.6 (15.9) mm Hg before PP to 94.9 (28.3) mm Hg during PP (difference, 21.3 mm Hg [95% CI, 6.3-36.3]; P = .006) (Figure). No significant difference was found between Pao2 before PP and Pao2 after resupination (P = .53). None of the included patients experienced major complications. Back pain was reported by 10 patients (42%) during PP. At the end of a 10-day follow-up period, 5 patients required invasive mechanical ventilation. Four of them did not sustain PP for 1 hour or more and required intubation within 72 hours.

Discussion

In this study of patients with COVID-19 and hypoxemic respiratory failure managed outside the ICU, 63% were able to tolerate PP for more than 3 hours. However, oxygenation increased during PP in only 25% and was not sustained in half of those after resupination. These results are consistent with findings from previous small studies of PP in nonintubated patients.5,6 A trial of PP may be a mechanism to select patients who will do well or it may be useful in a subset.

The study had several limitations. The sample was small, a single episode of PP was evaluated, the follow-up was short, clinical outcomes were not assessed, and causality of the observed changes cannot be inferred.

Further studies to identify optimal PP regimens and patients with COVID-19 in whom it may be beneficial are warranted.

Research Letter May 15, 2020

Respiratory Parameters in Patients With COVID-19 After Using Noninvasive Ventilation in the Prone Position Outside the Intensive Care Unit

Chiara Sartini, Moreno Tresoldi, Paolo Scarpellini, et al

JAMA. Published online May 15, 2020. doi:10.1001/jama.2020.7861

The pandemic of coronavirus disease 2019 (COVID-19), with a large number of patients requiring respiratory support, threatens to overload intensive care units (ICUs). Noninvasive ventilation (NIV) use in general wards may be an alternative for some patients but has seldom been described and is not used worldwide.1One study described the feasibility of NIV in the prone position2; pronation can recruit dorsal lung regions and drain airway secretions, improving gas exchange and survival in acute respiratory distress syndrome (ARDS).3 We report respiratory parameters after using this intervention in a case series of patients with COVID-19.

Methods

On April 2, 2020, in San Raffaele Scientific Institute, Milan, Italy, COVID-19 patients with ARDS were treated either in the ICUs (n = 48) or medical wards (n = 202). Noninvasive ventilation was used for 62 patients with mild to moderate ARDS who had saturation less than 94% on face mask with high-oxygen concentration, applying 10 cm H2O continuous positive airway pressure and 0.6 fraction of inspired oxygen (Fio2). In case of poor response to NIV, the intensive care surgeon suggested a trial of NIV in the prone position, which was continued if there was improvement in the first hour of treatment. Noninvasive ventilation cycles were individualized based on a patient’s severity of illness, adherence to the treatment, and dyspnea in the periods without NIV.

On April 2, 2020, we performed a cross-sectional survey to identify all patients undergoing the prone position NIV outside the ICU, irrespective of the day they started using this technique. Respiratory parameters were measured at 3 time points: before NIV, during NIV in pronation (60 minutes after start), and 60 minutes after NIV end. We investigated oxygen saturation as measured by pulse oximetry (Spo2), derived Pao2:Fio2,4 respiratory rate, and patient’s comfort using a numerical rating scale (0, totally uncomfortable, to 10, fully comfortable). Follow-up was conducted at 14 days to determine how many patients were discharged, were still treated in the prone position, or were intubated. Continuous measures were compared using Wilcoxon matched pairs signed rank test or t test if paired data were normally distributed. Two-sided P < .05 defined statistical significance. All analyses were performed with STATA version 16 (STATA Corp). The study was approved by the Ethics Committee of IRCCS San Raffaele Scientific Institute. Written informed consent was obtained.

Results

Fifteen patients receiving NIV in the prone position outside the ICU on April 2 were identified. Mean (SD) age was 59 years (6 years); 13 were men. Noninvasive ventilation in the prone position started a median of 5 days (interquartile range [IQR], 3-10 days) before April 2 (Table) and no patient started NIV in the prone position on April 2. The median number of NIV cycles in the prone position on April 2 was 2 (IQR, 1-3 cycles) for a total duration of 3 hours (IQR, 1-6 hours). Compared with baseline, all patients had a reduction in respiratory rate during and after pronation (P < .001 for both) (Figure); all patients had an improvement in Spo2 and Pao2:Fio2 during pronation (P < .001 for both); 12 patients (80%) had an improvement in Spo2 and Pao2:Fio2 after pronation; 2 (13.3%) had the same value; and 1 (6.7%) had worsened. Compared with baseline, 11 patients (73.3%) had an improvement in comfort during pronation and 4 (26.7%) had the same value; 13 patients (86.7%) had an improvement in comfort after pronation and 2 (13.3%) had the same value. At the 14-day follow-up, 9 patients were discharged home, 1 improved and stopped pronation, 3 continued pronation, 1 patient was intubated and admitted to ICU, and 1 patient died.

Discussion

Providing NIV in the prone position to patients with COVID-19 and ARDS on the general wards in 1 hospital in Italy was feasible. The respiratory rate was lower and the oxygenation was higher during and after pronation than they were at baseline. Whether intubation was avoided or delayed remains to be determined.

Limitations include the small number of patients, short duration of NIV in the prone position, and lack of a control group. Comparisons of NIV in the prone position with oxygen by face mask or NIV in the standard position are needed. Importantly, selection bias is possible. Patients were not included if NIV failed while in the prone position or were treated and either died or recovered before April 2. Therefore, patients in the study may not be representative of all patients treated with NIV in the prone position.

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