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PranNiti Oxygen Device Versus Regular Oxygen therapy in patients with low oxygen after surgery

A Comparative Study of PranNiti and Standard Oxygen Therapy in Post- Extubation Patients with Type I Respiratory Failure - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077664
Enrollment
100
Registered
2024-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: PranNiti Oxygen device: Oxygen will be administered to the participants using PranNiti Oxygen device with input oxygen flows of 4 liter per minute. Any escalation of Oxygen flows will b

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 1 respiratory failure Spo2 less than 96 respiratory rate less than 30

Exclusion criteria

Exclusion criteria: Patients with baseline spo2 greater than 96 Parturient refusal to consent Severe Respiratory failure with Spo2 less than 85 RR more than30 Clinically significant respiratory distress, for example retractions, grunting, cyanosis, possible Co2 narcosis. severe comorbidities like severe heart failure, pregnancy, etc. nasal injury, emphysematous bullae, severe valvular heart disease, cyanotic heart disease and nasal surgery

Design outcomes

Primary

MeasureTime frame
Absolute changes in arterial partial pressure of oxygen (PaO2)Timepoint: 30 minutes after initiation of oxygen therapy.

Secondary

MeasureTime frame
SpO2 Cerebral and somatic oxygenation PaCO2 (arterial partial pressure of carbon dioxide) Respiratory Rate O2 flow and total O2 utilization Episodes of disconnectionTimepoint: every 5 minute till 30 minutes after initiation of oxygen therapy.

Countries

India

Contacts

Public ContactAshish Singh Aditya

Post Graduate Institute of Medical Education & Research (PGIMER)

ashish09399@gmail.com09914406496

Outcome results

None listed

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