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HFNC versus Conventional oxygen therapy to facilitate extubation in critically ill children

HIGH FLOW NASAL CANNULA VERSUS CONVENTIONAL OXYGEN THERAPY AND INCIDENCE OF POST EXTUBATION AIRWAY OBSTRUCTION IN PICU: AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL (HiFloCOT-PICU trial) - HiFloCOT-PICU trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035546
Enrollment
110
Registered
2021-08-10
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: J988- Other specified respiratory disorders

Interventions

Intervention1: High Flow Nasal Cannula: Heated Humidified High Flow Nasal cannula will be applied immediately following extubation in PICU for minimum of 48 hours post extubation Control Intervention1

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated Duration of Mechanical Ventilation: >72 hours Children who completed the Spontaneous Breathing Trial (SBT) and ready for extubation.

Exclusion criteria

Exclusion criteria: Age 12 years Mechanical ventilation Mechanical ventilation via tracheostomy tube Children with neuromuscular disorder (LGBS, SMA etc.) Postsurgical patients (head and neck surgery, upper GI surgery, airway malformation, difficult airway) Children with major congenital malformations Children with chronic lung disease Children with congenital heart disease Parents not willing for the consent

Design outcomes

Primary

MeasureTime frame
The rate of Post extubation airway obstruction (PEAO) in HFNC versus COT groups in critically ill childrenTimepoint: Within 48 hrs of extubation—

Secondary

MeasureTime frame
Safety of use of HFNC versus COT in relation to nasal trauma, pneumothorax, nasal obstruction, gastric distensionTimepoint: within 48 hrs of extubation;The difference in physiological and respiratory parameters (heart rate, respiratory rate, blood pressure, and SpO2)Timepoint: within 48 hrs of extubation;The rate and number of nebulization (adrenaline or budesonide)Timepoint: within 48 hrs of extubation;The rate of extubation failure (need of re-intubation)Timepoint: within 48 hrs of extubation;The rate of treatment failure leading to escalation of respiratory support (CPAP, NIV, or BiPAP)Timepoint: within 48 hrs of extubation—

Countries

India

Contacts

Public ContactDr SUDEEP K C

PostGraduate Institute of Medical Education and Research, PGIMER, Chandigarh

sudeepkecy2011@gmail.com8448113960

Outcome results

None listed

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