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How effective and safe to give oxygen therapy in children suffering from respiratory disease who requires oxygen therapy by using a medical device named as Heated Humidified High Flow Nasal Canula (HHHFNC)

EFFICACY AND SAFETY OF EARLY HEATED HUMIDIFIED HIGH FLOW NASAL CANNULA OXYGEN THERAPY IN CHILDREN WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE: AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037648
Enrollment
80
Registered
2021-10-28
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: J219- Acute bronchiolitis, unspecified Health Condition 2: J13- Pneumonia due to Streptococcus pneumoniae Health Condition 3: J159- Unspecified bacterial pneumonia

Interventions

Intervention1: HHFNC OXYGEN THERAPY: child with acute hypoxaemic respiratory failure with SPO2 between 90% to 92% will be given HHHFNC therapy and will be reassed after 10 minutes . if spo2 improves c

Sponsors

Chacha Nehru Bal Chikitsalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)transcutaneous oxygen saturation (spo2) lessthan 92%at room air 2) respiratory rate more than upper limit of normal range for age 3) oxygen therapy started less than 4 hours of admission to emergency ward

Exclusion criteria

Exclusion criteria: 1)Upper airway obstruction 2)children with immediate need for intubation 3) modified glassgow coma scale (GCS) lessthan 8 4)all diagnosed heart diseases 5)covid patient

Design outcomes

Primary

MeasureTime frame
to determine the proportion of children eith acute hypoxaemic respiratory failure ((AHRF) RECEIVING EARLY HEATED HUMIDIFIED HIGH FLOW NASAL CANULA (HHHFNC) oxygen therapy requiring finally escalation of therapy in the form of contineous positive airway pressure support(CPAP) and intubation followed by mechanical ventilation in comparison to those receiving conventional oxygen therapyTimepoint: 24 hour and 7 days and at discharge from Pediatrics Intensive Care Unit—

Secondary

MeasureTime frame
to compare in two groups 1. length of stay in pediatrics intensive care unit 2.mortality 3.improvement in respiratory distress 4.improvement in comfort level scale 5.complication in the form of air leak(pneumothorax,pneumediastinum)nasal canula (defined as erythema or erosion of nasal mucosa,nares or septum)Timepoint: september 2021 to august 2022—

Countries

India

Contacts

Public ContactDr Sudarshan Dev Arya

CHACHA NEHRU BAL CHIKITSALAYA

DRSAIKIADIGANTA@GMAIL.COM9899023635

Outcome results

None listed

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