Trial NCT04609462
Publication Ospina-Tascon GA, JAMA, 2021 (published paper)
Dates: 2020-08-13 to 2021-01-12
Funding: Public/non profit (Centro de Investigaciones Clínicas, Fundación Valle del Lili)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Colombia Follow-up duration (days): 28 | |
Inclusion criteria | Aged 18 years or older; suspected or confirmed infection with SARS-CoV-2 (confirmation via reverse transcriptase–polymerase chain reaction test from a nasopharyngeal swab); acute respiratory failure with a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) of less than 200, accompanied by clinical signs of respiratory distress (eg, use of accessory muscles and respiratory rate greater than 25/min); less than 6 hours elapsed since fulfilling the criteria of acute respiratory failure; admitted to the emergency department, general ward, or intensive care unit. |
Exclusion criteria | Need for immediate endotracheal intubation; a partial pressure of arterial carbon dioxide greater than 55 mm Hg; pregnancy; high suspicion or confirmation of acute cardiogenic pulmonary edema; history of or current left ventricular ejection fraction of less than 45%; history of chronic heart failure (New York Heart Association class III-IV); clinical suspicion or confirmation of peripheral demyelinating disease; history of advanced chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease grade C-D) or hospitalization due to chronic obstructive pulmonary disease decompensation within the last year; advanced liver cirrhosis (Child-Pugh class C); anatomical or other conditions precluding the use of a high-flow nasal cannula; do-not-intubate or do-not-resuscitate orders; imminent death; and refusal of study participation by a patient or their next of kin. |
Interventions | |
Treatment
High-flow nasal oxygenation Nasal oxygenation 60 L/min and an Fio2 of 1.0 continuously applied through large-bore binasal prongs using heated and humidified gas. Fio2 was adjusted to maintain pulse oxygen saturation (Spo2) values of 92% or greater until intubation or when criteria for weaning of high-flow oxygen therapy were achieved. |
|
Control
Conventional oxygen therapy ( / ) | |
Participants | |
Randomized 220 participants (n1= / n2= ) | |
Characteristics of participants N=220 Mean age : NR 134 males Severity : Mild: n=0 / Moderate: n=38/ Severe: n=161 Critical: n=0 | |
Primary outcome | |
In the register Intubation rate [ Time Frame: 28 days ]; Clinical recovery [ Time Frame: 28 days ] | |
In the report Need for intubation and time to clinical recovery within 28 days after randomization. | |
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 prospective protocol, statistical analysis plan, supplemental appendices and retrospective study registry were used in data extraction and risk of bias assessment. There is no change from the registry or protocol in the intervention and control treatments. The primary and secondary outcomes in the article reflected those in the registry and the protocol. No amendments are reported of outcomes in the prospective version of the protocol. The trial (n = 220) achieved its target sample size (n = 220). |