Trial NCT04221737
Publication Ibarra-Estrada MA, Crit Care Med (2021) (published paper)
Dates: 2020-03-01 to 2020-11-30
Funding: Not reported/unclear
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Mexico Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
APR ventilation 12-hour stabilization period of protective LTV ventilation followed by management with APRV. |
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Control
LTV ventilation | |
Participants | |
Randomized participants : APR ventilation=51 LTV ventilation=50 | |
Characteristics of participants N= 101 Mean age : NR 63 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=90 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Mechanical ventilation free days [ Time Frame: 28 days ] | |
In the report Ventilator-free days (VFDs) at 28 days. | |
Documents available |
Protocol Yes. In English Statistical plan Yes 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 protocol, analysis plan, supplementary appendices and the prospective study registry were used in data extraction and risk of bias assessment. 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=90) did not achieve the target sample size specified in the trial registry (n=150) or as calculated in the paper (n=130). Of note: a non-prespecified interim analysis following four cases of barotrauma resulted in termination of COVID patient enrollment in the study while enrollment remains ongoing for non-COVID ARDS patients." |