Trial CTRI/2020/07/026835
Publication Nair PR, Respir Care, 2021 (published paper)
Dates: 2020-08-01 to 2020-12-30
Funding: Public/non profit (All India Institute of Medical Sciences New Delhi )
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / India Follow-up duration (days): 28 | |
| Inclusion criteria | Adult subjects of age 18–75 y; laboratory-confirmed diagnosis of COVID-19 pneumonia; presenting with severe COVID-19 pneumonia (Subjects presenting with fever, cough, and respiratory distress with frequency > 30 breaths/min and/or room air SpO2 < 90%); failed oxygen therapy by face (frequency > 24 breaths/min and/or SpO2 < 94% in spite of oxygen by face mask at 10 L/min flow for 30 min); informed written consent from the subjects or their legally acceptable representatives. |
| Exclusion criteria | Hemodynamic instability and requirement of high-dose vasopressor therapy; pregnancy; COPD/chronic respiratory failure; morbid obesity; patients with urgent requirement of invasive mechanical ventilation, severe hypoxia (SpO2 < 90% with frequency > 40 breaths/min for > 10 min), severe hemodynamic instability (mean arterial pressure < 65 mm Hg in spite of high-dose noradrenaline support) with altered mentation, Glasgow coma scale score < 8, or cardiac arrest. |
| Interventions | |
| Treatment
High flow nasal cannula HFNC through large-bore binasal prongs with a high-flow heated humidifier device. The initial gas flow was set at 50 L/min and FIO2 of 1.0. The flow and FIO2 were subsequently adjusted between 30–60 L/min and 0.5–1.0, respectively, to maintain SpO2 of 94% or more. |
|
| Control
Noninvasive ventilation ( / ) | |
| Participants | |
| Randomized 109 participants (n1= / n2= ) | |
| Characteristics of participants N=109 Mean age : NR 79 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=109 Critical: n=0 | |
| Primary outcome | |
| In the register Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission | |
| In the report Early intubation rate, proportion of subjects requiring invasive mechanical ventilation at 48 h of ICU admission | |
| 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 registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry has different timepoints than the primary outcome reported in the paper. The study (n = 109) achieved its target sample size (n = 100). PERSONAL COMMENTS (TO BE REMOVED - PASTED HERE IN CASE THEY DO NOT SAVE IN THE PERSONAL COMMENTS TAB): 1) Mortality (D28) and Time to death are for in-hospital mortality 2) Viral RNA test positive: Extracted as all participants. Inclusion criterion is “laboratory confirmed” and at the time of recruitment laboratory-based antigen tests were uncommon. 3) Vaccinated: Extracted as Zero based on recruitment dates. 4) Asthma/COPD: Extracted as “*”. COPD/chronic respiratory failure are exclusion criteria, but no mention of asthma. |