Skip to content

Comparison of two different types of simple non-invasive oxygen therapy devices in coronavirus lung infection

Comparison of High Flow Nasal Oxygen and Non Invasive Ventilation in Acute Hypoxemic Respiratory Failure due to Severe COVID-19 pneumonia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026835
Enrollment
100
Registered
2020-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J128- Other viral pneumonia

Interventions

Intervention1: High Flow Nasal Oxygen therapy: Patients allocated to HFNO arm will be applied HFNO through large-bore binasal prongs with a high flow heated humidifier device (Optiflow, Fisher and Pay

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor
All India Institute of Medical Sciences New Delhi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: One hundred adult patients (aged between 18 and 75y) with laboratory confirmed diagnosis of COVID-19 pneumonia, presenting with severe COVID-19 pneumonia, who fail oxygen therapy by facemask, will be included in this study after ethics committee approval and informed written consent from the patients or their legally acceptable representatives.

Exclusion criteria

Exclusion criteria: Following patients will be excluded i) refusal to participate, ii) hemodynamically unstable patients on high dose vasopressor therapy iii) pregnant patients iv) COPD / chronic respiratory failure v) Morbid obesity vi) Patients with urgent requirement of invasive mechanical ventilation

Design outcomes

Primary

MeasureTime frame
Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admissionTimepoint: Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission

Secondary

MeasureTime frame
1. Early improvement in oxygenation â?? SpO2, RR and PaO2/FiO2 ratio in arterial blood gas at 2 hours and 24 hours 2. Late intubation rate - proportion of patients requiring invasive mechanical ventilation within day 7 of ICU admission 3. Proportion of patients requiring awake prone positioning within 48 hours 4. In-hospital mortality Timepoint: 2 hours, 24 hours, 48 hours and 7 day

Countries

India

Contacts

Public ContactDalim Kumar Baidya

AIIMS New Delhi

dalimkumar.ab8@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026