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A study comparing 21 percent and 40 percent oxygen concentration during high flow nasal cannula therapy in children with acute bronchiolitis admitted to the pediatric intensive care unit

Initiation of Heated Humidified High-Flow Nasal Cannula Therapy with 21 % Versus 40 % FiO2 in Children with Acute Bronchiolitis Admitted to the Pediatric Intensive Care Unit : A Pilot Randomized Controlled Trial - INHALE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109618
Enrollment
50
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: J219- Acute bronchiolitis, unspecified

Interventions

Intervention1: 21 HFNC: Initiating HHHFNC with 21 percent fraction of inspired oxygen Control Intervention1: 40 HFNC: initiating HHHFNC with 40 percent fraction of inspired oxygen

Sponsors

Arvind Krishna Dhakshinmurthy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 1 month and 24months with Presence of respiratory distress is defined as presence 1)Tachypnea with Respiratory rate : 1month to 2months more than 60 per min 3months to 12months more than 50per min 13months to 24months morethan 40per min (or) 2)increased work of breathing - Chest indrawing or retractions (subcostal or intercostal or suprasternal retraction) or Nasal flaring

Exclusion criteria

Exclusion criteria: 1)Children with hemodynamic instability requiring inotropes 2)Known congenital heart disease 3)Craniofacial malformation 4)Altered sensorium 5) Apnea 6)Bradycardia 7)Cyanosis

Design outcomes

Primary

MeasureTime frame
To determine the incidence of primary treatment escalation and secondary treatment escalationTimepoint: baseline (0 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes, and 360 minutes, followed by 6-hourly assessments for up to 96 hours or until HFNC is successfully weaned, whichever occurs earlier

Secondary

MeasureTime frame
To determine the rate of HFNC failureTimepoint: 96hours;To determine the time required for resolution of respiratory distress,Timepoint: 96 hours;To compare the change in ROX index between the two groups at predefined time points baseline 0 hours 6 hours 12 hours 18 hours 24 hours36 hours and 48 hoursTimepoint: 96 hours;To determine the length of PICU stay and total hospital stay in both groups.Timepoint: 96 hours

Countries

India

Contacts

Public ContactArvind krishna Dhakshinamurthy

Mehta Multispecialty Hospital

sasidarpgi@gmail.com9677275167

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026