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ROLE OF BREATHING SUPPORT DURING ENDOTRACHEAL TUBE PLACEMENT IN NEWBORNS

ROLE OF RESPIRATORY STABILISATION FOR SUCCESSFUL INTUBATION IN NEONATES: A RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051946
Enrollment
150
Registered
2023-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Respiratory support during endotracheal intubation: Respiratory support will be provided in the form of heated humidified high flow nasal cannula (HHHFNC)/ continuous positive airway pr

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH
Lead Sponsor
POONAM SINGH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates undergoing endotracheal intubation in NICU.

Exclusion criteria

Exclusion criteria: 1. Heart rate 2. Life threatening congenital anomalies 3. Cyanotic congenital heart disease 4. Need for intubation on emergency basis as determined by treating clinician 5. Failure to obtain consent

Design outcomes

Primary

MeasureTime frame
Rate of successful intubation in first attempt without physiological instability (HR100/min and/or decrease in SpO220% from the baseline)Timepoint: 5-minutes after endotracheal intubation

Secondary

MeasureTime frame
1. Overall rate of first attempt successful intubation (with/without physiological instability) 2. Number of intubation attempts 3. Change in regional cerebral oxygen saturation 4. Change in SpO2 and heart rate during intubation 5. Rate of desaturation or bradycardia 6. Time to desaturation and bradycardia in seconds 7. Minimum peripheral oxygen saturation 8. Minimum heart rate during intubation 9. Median duration of SpO2 less than 95% in seconds 10. Cumulative duration of desaturation and bradycardia in all intubation attempts 11. Incidence of adverse eventsTimepoint: Within 72 hours of randomization

Countries

India

Contacts

Public ContactPoonam Singh

All India Institute of Medical Sciences, Rishikesh

deekshagupta93@gmail.com

Outcome results

None listed

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