Trial CTRI/2020/12/029702
Publication Jayakumar D, J Intensive Care Med, 2021 (published paper)
Funding: No specific funding (Unfunded trial)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / India Follow-up duration (days): 28 | |
| Inclusion criteria | ≥18 years; admitted to the intensive care unit; proven or suspected COVID-19 infection leading to hypoxic respiratory failure (requiring 4 or more litres per minute of supplemental oxygen to maintain SpO2 ≥92% or if ABG was available, PaO2/FiO2 ratio between 100 and 300 mmHg (mild to moderate ARDS) with PaCO2 less than 45 mmHg, or AHRF and haemodynamic shock requiring <0.1mcg/kg/min of norepinephrine) |
| Exclusion criteria | Patients below 18 years of age; pregnant women; patients with hemodynamic shock requiring norepinephrine ≥ 0.1 mcg/kg/min; any GCS <15; patients who needed immediate intubation in the opinion of the treating clinician; patients with absolute or relative contraindications to prone positioning (spinal instability secondary to severe rheumatoid arthritis, life threatening cardiac arrhythmias) |
| Interventions | |
| Treatment
Awake-Prone Positioning Strategy ≥6 hours per day cumulative for 7 days |
|
| Control
Standard care ( / ) Definition of Standard care: Oxygen via nasal prongs, face mask (up to 10 LPM oxygen flow rate was allowed), non-rebreather mask (oxygen flow adjusted to maintain a saturation of ≥92%), high flow nasal cannula (flow was set at maximum permissible level on the device used or 60 liters per minute in case of blenders, and FiO2 adjusted to the goal ≥92%) or Non-invasive ventilation (titrated to maintain SpO2 ≥92%) as per treating clinician discretion | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 56.1 50 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=60 Critical: n=0 | |
| Primary outcome | |
| In the register Proportion of patients adhering to the protocol, timepoint: 2 weeks | |
| In the report Proportion of patients adhering to the protocol | |
| 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 journal/pre-print article, the prospective study registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. This was a feasibility study and sample size was not pre-calculated. In the intervention group only 43% could adhere to the protocol which required 6 hours of cumulative prone positioning. 53% in the control group spent some hours in the prone position, but none exceeded 6 hours of prone positioning amounting to protocol violation. There is no change from the trial registration in the intervention and control treatments. The primary outcome (not extracted) was at 2 weeks in the registry but at 1 week in the article.
On 17th of May, 2021, this study was updated based on the published report. |