Trial NCT04581811
Publication Page DB, Ann Am Thorac Soc, 2021 (published paper)
Dates: 2020-11-10 to 2021-01-12
Funding: No specific funding (None)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Single center / USA
Follow-up duration (days): 30
Inclusion criteria1) at least 18 years of age; 2) endotracheally intubated; 3) had a PaO2:FiO2 (P:F) of <150 on at least 0.6 FiO2 and 10 cm H2O of positive end-expiratory pressure; 4) had COVID-19-induced-ARDS
Exclusion criteria 1) had a do not attempt resuscitation order; 2) were a prisoner or pregnant; 3) had been intubated for more than 48h at the time of screening; 4) had a contraindication to prone positioning.
Interventions
Treatment
Prolonged Proning
24-hour prolonged prone positioning followed by up to 8-hour supine positioning. Return to prone position within 8 hours if the P:F ratio was <150 on 0.6 FiO2 and 10 cm H2O
Control
Traditional Proning ( / )
Participants
Randomized
52 participants (n1=26 / n2= 26)
Characteristics of participants
N=52
Mean age : 63
32 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=52
Primary outcome
In the register
Duration in prone position [ Time Frame: 96 hours ]
In the report
duration proned
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment “In addition to the published article, the prospective study registry was used in data extraction and risk of bias assessment. Neither the protocol nor statistical analysis plan were available. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. The study (n = 52) achieved its target sample size (n = 52)."