| CTRI Number |
CTRI/2025/07/090210 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two techniques of oxygen delivery to reduce the complications during endotracheal intubation in neonates |
|
Scientific Title of Study
|
Intraprocedural nasal HHHFNC versus Free Flow Oxygen for the Successful Endotracheal Intubation in Neonates: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Soni |
| Designation |
Senior Consultant, Department of neonatology |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of neonatology
Sir Ganga Ram Hospital New Delhi INDIA
Central DELHI 110060 India |
| Phone |
9810634043 |
| Fax |
|
| Email |
arun00soni@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Satish Saluja |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of neonatology
Sir Ganga Ram Hospital
New Delhi
Department of neonatology
Sir Ganga Ram Hospital
New Delhi Central DELHI 110060 India |
| Phone |
9811047389 |
| Fax |
|
| Email |
satishsaluja@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nandha Kumar |
| Designation |
DrNB resident |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology
Sir Ganga Ram Hospital New Delhi INDIA
Central DELHI 110060 India |
| Phone |
7904282446 |
| Fax |
|
| Email |
drnandhakumar93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Gangaram Hospital, rajinder nagar, New delhi- 110060 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Soni |
| Address |
Senior Consultant, Department of neonatology
Sir Ganga Ram Hospital, New Delhi-110060, INDIA
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Arun Soni |
Sir Ganga Ram Hospital |
F-47, Department of neonat1st floor,
Sir Ganga Ram Hospital, New Delhi-110060, India
Central DELHI |
9810634043
arun00soni@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
free flow oxygen therapy during endotracheal intubation |
Free flow oxygen therapy will be given at 5 litres /min through oxygen tubing held with cupped hand near the nostril during endotracheal intubation in neonates. |
| Intervention |
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 (6l/min for neonates 32 weeks and 8l/min 32 weeks) during endotracheal intubation in neonates. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Male and female neonates of all gestational ages. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| successful endotracheal intubation in first attempt heart rate more than hundred beats per minute, fall in spo2 less than twenty percent from baseline. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation (ETI) is one of the most common emergency procedures performed in the neonatal intensive care unit (NICU). As a convention before endotracheal intubation, the baby is either preoxygenated with 100% oxygen through bag and mask ventilation or free flow oxygen is administered during the procedure. The use of heated humidified high flow nasal cannula (HHHFNC) therapy has been tried to improve the success of endotracheal intubation in neonates. Recently it has been shown to decrease the intraprocedural physiological instability i.e., oxygen desaturation to <20% from baseline and bradycardia in neonates. To evaluate this, we plan to conduct this randomized control trial, where the study participants will be divided into two groups (HHHFNC group and free flow oxygen group) enrolling 110 intubations in each group, consisting of neonates of all gestational ages admitted in NICU who will be requiring endotracheal intubation. The primary outcome will be the successful endotracheal intubation, defined as endotracheal intubation in the first attempt not associated with oxygen desaturation to <20% from baseline and bradycardia (heart rate <100 bpm). The secondary outcome measures will include cumulative durations of oxygen desaturation <20% from baseline and bradycardia (hear rate <100 bpm), median heart rate and spo2 during the procedure and number of intubation attempts. We expect that using high flow oxygen compared to free flow oxygen during the procedure will increase endotracheal intubation success rate. |