Trial CTRI/2021/01/030829
Publication Nazir N, Research Square, 2021 (preprint)
Dates: 2021-02-05 to 2021-04-28
Funding: No specific funding (None)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / India Follow-up duration (days): 14 | |
| Inclusion criteria | COVID positive patients ; age ≥ 16 years ; informed consent ; Pneumonia with no signs of severe disease with clinical features consisting of dyspnoea (respiratory rate 24–30/min), hypoxia (SpO2: ≤ 94% [range 90–94%] on room air), fever and cough. |
| Exclusion criteria | Pneumonia with signs of severe disease with clinical features consisting of respiratory distress (respiratory rate > 30/min), hypoxia (SpO2: < 90% on room air), fever and cough; Glasgow Coma scale ≤ 12; primary pulmonary disease; tracheostomy; any nasal/facial defect that could impede HFNC or NRBM use. |
| Interventions | |
| Treatment
High flow nasal cannula The assigned treatment was administered continuously and patients were assessed for treatment success. Patients were weaned to a lower FiO2 oxygen therapy device when the following criteria were met: respiratory rate ≤ 24 breaths/min; no recruitment of accessory muscles during calm breathing; haemodynamic stability (HR < 120/min; MAP between 70 and 110 mmHg with no hemodynamically significant arrhythmias), PaO2 > 80 and SpO2 ≥ 96% |
|
| Control
Non-rebreathing mask ( / ) | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 56.8 30 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Primary outcomes noted will be number of patients and time to progression to severe disease. 0,1,2, to 14 days | |
| In the report Success of oxygen therapy which was defined as not requiring replacement to a higher oxygen delivery device and the time to progression to severe disease. | |
| Documents available |
Protocol NR Statistical plan NR 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 pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were no major differences between the article and the registry in population, procedures, intervention or outcomes. The study achieved its target sample size. The outcome, WHO score 7 and above (D28), will be rechecked after contacting the author. |