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Comparison of two techniques of oxygen delivery to reduce the complications during endotracheal intubation in neonates

Intraprocedural nasal HHHFNC versus Free Flow Oxygen for the Successful Endotracheal Intubation in Neonates: A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090210
Enrollment
220
Registered
2025-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period

Interventions

Intervention1: Heated Humidified high flow oxygen therapy during endotracheal intubation: Heated humidified high flow oxygen therapy will be given through Opti flow nasal canula at different flow rate

Sponsors

Dr Arun Soni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male and female neonates of all gestational ages.

Exclusion criteria

Exclusion criteria: requirement for immediate endotracheal intubation as determined by treating clinician, insufficient time for the researcher to randomize and setup study equipment, unable to achieve spo2 more than ninety percent prior to intubation, heart rate less than hundred beats per minute prior to randomization, contraindications to HFNC like congenital upper airway anomaly, congenital diaphragmatic hernia, abdominal wall defect, congenital cyanotic heart disease, failure to obtain consent.

Design outcomes

Primary

MeasureTime frame
successful endotracheal intubation in first attempt heart rate more than hundred beats per minute, fall in spo2 less than twenty percent from baseline.Timepoint: Baseline

Secondary

MeasureTime frame
cumulative duration of oxygen desaturation more than twenty percent from baseline, cumulative duration of bradycardia heart rate less than hundred beats per minute, number of attempts for intubation, duration of intubation attempts, adverse events during intubation, severe like esophageal intubation with delayed recognition, airway trauma, hypotension, pneumothorax, pneumomediastinum, non severe esophageal intubation with immediate recognition, mainstem bronchial intubation, oral or airway bleeding, lip trauma.Timepoint: Baseline

Countries

India

Contacts

Public ContactDr Nandha Kumar

Sir Ganga Ram Hospital

satishsaluja@gmail.com9811047389

Outcome results

None listed

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