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Clinical Trials/CTRI/2021/04/033175
CTRI/2021/04/033175
Active, Not Recruiting
Phase 3

A randomised controlled trial of oxygen delivery through nasal cannula or NIP masks in patients with confirmed COVID 19 infection: The PROVE Trial - PROVE

George Institute for Global Health India0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
George Institute for Global Health India
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
George Institute for Global Health India

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \>\= 18 years
  • •2\. Laboratory confirmed COVID\-19 positive infection
  • •3\. Requiring more than 40% oxygen (FiO2 \> 0\.4\) â?? (requiring 6L or more of oxygen by Hudson mask
  • •or nasal cannula) to maintain SpO2 \>93%

Exclusion Criteria

  • •1\. Obtunded
  • •2\. The attending clinician is not committed to patient receiving mechanical ventilatory support
  • •3\. In the opinion of the treating clinician the patient is in respiratory distress and is eminently
  • •requiring escalation of treatment including intubation and mechanical ventilation
  • •4\. Currently receiving either CPAP, BiPAP, high flow nasal prongs or mechanical ventilation
  • •5\. Participants usually on home ventilation (either CPAP or BiPAP)
  • •6\. Previous participation in PROVE trial
  • •7\. Known or suspected pregnancy
  • •8\. Enrolment in the study is not in the best interest of the patient as deemed by the treating clinician

Outcomes

Primary Outcomes

Not specified

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