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Clinical Trials/CTRI/2025/12/099711
CTRI/2025/12/099711
Not yet recruiting
Phase 2

A Randomized controlled study of neonates undergoing endotracheal intubation with high nasal flow oxygen VS standard care

DrHima Chandana Mankala1 site in 1 country50 target enrollmentStarted: January 10, 2026Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
DrHima Chandana Mankala
Enrollment
50
Locations
1
Primary Endpoint
to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care

Overview

Brief Summary

This study aims to evaluate the effectiveness of high-flow nasal oxygen in improving the success of the first endotracheal intubation attempt in neonates, compared with standard care. By closely observing clinical outcomes in both groups, the study seeks to determine whether the continuous oxygen delivery provided by high-flow nasal therapy helps maintain better oxygenation and physiological stability during the procedure. The investigation will assess not only the rate of first-attempt success but also associated factors such as heart rate changes, oxygen desaturation episodes, and overall intubation conditions. Through this comparison, the study intends to generate evidence on whether integrating high-flow nasal oxygen into neonatal airway management can enhance procedural safety and reduce complications during intubation.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
0.00 Day(s) to 28.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • all eligible neonates undergoing endotracheal intubation in KIMS NICU.

Exclusion Criteria

  • infants with oromaxillary and airway anomalies.

Outcomes

Primary Outcomes

to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care

Time Frame: to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care immediately after the intubation attempt -10 mins

Secondary Outcomes

  • To assess if time to desaturation is prolonged with high nasal flow oxygen via nasal prongs(10 mins of study)

Investigators

Sponsor
DrHima Chandana Mankala
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

HIMA CHANDANA MANKALA

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

Study Sites (1)

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