Skip to content

Comparing two oxygen delivery techniques in patients with breathing difficulty

CPAP using Helmet interface versus High Flow Nasal Cannula Device in SARI: A prospective, two arm,open labelled,randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027176
Enrollment
50
Registered
2020-08-17
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: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Intervention group: The patient in this groupwill be connected to CPAP helmet. The pressure, flow and Fio2 will be set by the intensivists as per the clinical condition of the patient

Sponsors

Dr D Vimal Bhardwaj
Lead Sponsor
InnAccel Technologies Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient aged more than or equal to 18 years, both the genders in the emergency and medical/surgical intensive care units 2. Requiring CPAP/HFNC support 3. Subject or legally authorized representative/patient relative willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Need for direct admission to the intensive care unit for mechanical ventilation 2. Unconscious or patient with drowsiness 3. Pneumothorax 4. Carbon dioxide pressure (pCO2) >45 mmHg in venous blood gas (VBG) 5. Haemodynamic instability (MAP 6. Pregnant women 7. Severe head/neck and facial injuries 8. Tracheostomy on admission 9. Patient enrolled in another study 10. Inability to comprehend the study content and give informed consent

Design outcomes

Primary

MeasureTime frame
Number of patients who did not progress to mechanical ventilation Timepoint: 28 days

Secondary

MeasureTime frame
Days alive withinTimepoint: 28 days and 180 days;Frequency of carbon dioxide rebreathingTimepoint: 28 days;Frequency of endotracheal intubationTimepoint: 28 days;Patient comfortTimepoint: 24 hours after randomisation;SpO2/FiO2 -ratioTimepoint: 1 hour after randomisation

Countries

India

Contacts

Public ContactDr Arjun Alva

Mazumdar Shaw Medical Center, Narayana Health city

vimal.bhardwaj.dr@narayanahealth.org9686124830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026