FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close