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 criteria |
|
Exclusion criteria |
|
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
Prone position 16-hour prone positioning followed by up to 8-hour supine positioning | |
Participants | |
Randomized participants : Prolonged Proning=26 Prone position=26 | |
Characteristics of participants N= 52 Mean age : NR 32 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=52 Number of vaccinated participants: NR | |
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 willing stated in the publication: Not reported |
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)." |