Study on the Effect of Early Non-Invasive Breathing Support in Patients with Severe Breathing Difficulty in the Emergency Department

Evaluating the Impact of Early Non-Invasive Ventilation (NIV) Strategies on Clinical Outcomes in Emergency Management of Acute Respiratory Failure Randomized controlled trail - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108115

Enrollment

Registered

2026-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: J969- Respiratory failure, unspecified

Interventions

Intervention1: Early NIV Group: Patients will receive early initiation of non-invasive ventilation NIV using CPAP or BiPAP based on clinical indication, along with standard medical management. Control

Eligibility

Inclusion criteria

Inclusion criteria: Respiratory rate more than 25 Use of accessory muscle Spo2 less than 90 percentage on room air or less than 92 % on supplementary oxygen ABG pH less than 7 35 PaCo2 more than 45mmhg PaO2 less than 60mmhg GCS score More than 13

Exclusion criteria

Exclusion criteria: Do not resuscitate Severe acidemia Need for immediate airway protection Poor secretion clearance

Design outcomes

Primary

Measure	Time frame
To assess clinical outcomes and hospital stay duration in patients managed with early NIV(Non-Invasive Ventilation) compared to Standard oxygen therapy in the emergencydepartmentTimepoint: At baseline (on presentation to the Emergency Department) At 24 hours after initiation of therapy At discharge from hospital	—

Secondary

Measure	Time frame
To evaluate ICU stay duration. To determine the rate of NIV(non invasive ventilation) failure requiring intubation. To assess patient comfort & tolerance levels.Timepoint: Assessed at the time of discharge from the ICU. Assessed at 6 hours, 12 hours, & 24 hours after initiation of NIV & during the entire hospital stay	—

Countries

India

Contacts

Public ContactDr Safdhar Hasmi

Aarupadai Veedu Medical College and Hospital, Puducherry

Veeraraghavanharibabu@gmail.com9442369647

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026