Skip to content

Comparing Oxygen Levels Produced by a locally developed device and a commercial High-Flow Oxygen Device Before General Anaesthesia

Effect On Preoxygenation Using an Indigenously Developed HFNC Device: A Randomized Non-Inferiority Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089111
Enrollment
124
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K639- Disease of intestine, unspecified Health Condition 2: K769- Liver disease, unspecified

Interventions

Intervention1: Indigenous HFNC device: Preoxygenation through indigenously developed TrueOxy+ HFNC device in Group A Control Intervention1: Standard HFNC Device: Preoxygenation through standard HFNC

Sponsors

Indian Council of Medical Research (ICMR), New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 50 years (Adult Patients) , 2. ASA PS I & II, 3. Adult patients who will undergo major abdominal surgery at the Main Operation Theatre (OT), Nehru Hospital & Extension, PGIMER, under general anaesthesia and requires arterial blood gas monitoring. 4. Patients with informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Less than 18 years and Greater than 50 years. 2. ASA PS III & IV 3. History of severe respiratory, cardio-vascular, renel, known case of asthma, COPD, nasal facial trauma. 4. Patient requiring oxygen supplementation before induction of Anaesthesia.

Design outcomes

Primary

MeasureTime frame
Difference in the PaO2 at the end of preoxygenation between the two devices, i.e., the TrueOxy+ HFNC device and the reference HFNC device (Fisher & Paykel Airvo 2 HFNC device).Timepoint: 1. 0 Minutes 2. 3 Minutes

Secondary

MeasureTime frame
EtO2, EtCO2, RR, BP, SpO2, HR levels during preoxygenation. Timepoint: (time frame: every 30 seconds till the end of preoxygenation (total 3-minute period));Other ABG parameters like pH, PCO2, HCO3, BE/BD from the sampleTimepoint: at the end of preoxygenation;Patient Comfort assessed on an ordinal scaleTimepoint: at the end of preoxygenation.

Countries

India

Contacts

Public ContactDr Shiv Lal Soni

Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA)

dr.shivsoni@gmail.com09914208550

Outcome results

None listed

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