Trial NCT04502576
Publication Grieco DL, JAMA, 2021 (published paper)
Dates: 2020-10-13 to 2020-12-13
Funding: Not reported/unclear (research grant (2017 Merck Sharp & Dohme SRL award) by the Italian Society of Anesthesia, Analgesia, and Intensive Care Medicine)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Italy Follow-up duration (days): 60 | |
| Inclusion criteria | Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FIO2) equal to or below 200; partial pressure of arterial carbon dioxide (PaCO2) equal to or lower than 45 mm Hg; absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (New York Heart Association class >II or left ventricular ejection fraction <50%); confirmed molecular diagnosis of COVID19; written informed consent |
| Exclusion criteria | Pregnancy; Body mass index>40; Exacerbation of asthma or chronic obstructive pulmonary disease; Known hypercapnia (PaCO2>45 mmHg) with or without respiratory acidosis; More than 2 organ failures, including the lung; Documented pneumothorax; Clinical diagnosis of Cardiogenic pulmonary oedema; Haemodynamic instability (Systolic blood pressure<90 mmHg or mean arterial pressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinically diagnosed; Shock requiring administration of vasoactive agents (norepinephrine>0.1 mcg/Kg/min); Metabolic Acidosis (ph <7.30 with normal- or hypo-carbia); Chronic kidney failure requiring dialysis before ICU admission; Chronic hypoxemic respiratory failure requiring long-term oxygen therapy; Altered neurological status that requires immediate intubation and/or making the patient uncooperative; Urgent need for endotracheal intubation, according to the decision of the attending physician; Do not intubate order; Decision of withdrawal of life-sustaining therapy; Thoracic or abdominal surgery in the previous 7 days; Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure; Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient’s face; Patients that have already received NIV continuously for more than 12 hours before the screening visit |
| Interventions | |
| Treatment
Helmet noninvasive ventilation continuous noninvasive ventilation positive endexpiratory pressure >=10 cm H2O, interruption attempted after 48 hours if FIO2 was =<40% and respiratory rate =<25 breaths/min |
|
| Control
High-flow nasal oxygenation ( / ) | |
| Participants | |
| Randomized 110 participants (n1= / n2= ) | |
| Characteristics of participants N=110 Mean age : NR 88 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=109 Critical: n=0 | |
| Primary outcome | |
| In the register Respiratory-support free days within 28 days from randomization [ Time Frame: 28 days | |
| In the report Number of days free of respiratory support (including high-flow nasal oxygen, noninvasive and invasive ventilation) within 28 days after enrollment | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| 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, statistical analysis plan, and prospective study registry were used in data extraction and risk of bias assessment. Ninety-day mortality and quality of life after 6 and 12 months were among the prespecified secondary outcomes, but results are not reported: the trial is listed as still active in the registry, so follow-up may be ongoing. The study was originally designed for patients with hypoxemic respiratory failure from all causes, but, due to the surge of the ongoing pandemic, only included patients diagnosed with COVID-19. The study achieved its prespecified target sample size. |