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 |
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Exclusion criteria |
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Interventions | |
Treatment
HFNC 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. |
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Control
NIV NIV with either mask/helmet device connected to an ICU ventilator with the setting of pressure support (PS) of 10–20 cm H2O adjusted with the aim of obtaining an expired tidal volume of 7–10 mL per kilogram of predicted body weight and PEEP 5–10 cm H2O and FIO2 0.5–1.0 titrated to target SpO2 > 94%. | |
Participants | |
Randomized participants : HFNC=55 NIV=54 | |
Characteristics of participants N= 109 Mean age : NR 79 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=109 Critical: n=0 Number of vaccinated participants: 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 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 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). |