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 | Ages 18 to 80 years; reverse transcriptase-polymerase chain reaction–confirmed COVID-19; Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2/FiO2 for altitude <300; less than 48 h of endotracheal mechanical ventilation. |
| Exclusion criteria | Pregnancy; Less than 18 years-old; Expected duration of mechanical ventilation less than 48 h; Preexisting conditions with an expected 3-month mortality exceeding 50%; Concurrent chemotherapy; Confirmed intracranial hypertension; Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation; Pneumothorax at enrollment (resolved or not); Do-not-resuscitate order. |
| Interventions | |
| Treatment
Airway pressure release ventilation (APRV) 12-hour stabilization period of protective LTV ventilation followed by management with APRV. |
|
| Control
low tidal volume (LTV) ventilation ( / ) | |
| Participants | |
| Randomized 101 participants (n1=51 / n2= 50) | |
| Characteristics of participants N=101 Mean age : 56 63 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=90 | |
| 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 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 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." |