| CTRI Number |
CTRI/2024/09/073734 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of high flow nasal cannula versus non rebreathing mask during endotracheal intubation |
|
Scientific Title of Study
|
Efficacy of High Flow Nasal Cannula Versus Non- Rebreathing Mask During Endotracheal Intubation In critically ill Children : A Randomised Clinical Trial |
| 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 Anil sachdev |
| Designation |
Chairman , department of pediatrics |
| Affiliation |
Sir gangaram hospital , rajinder nagar , new delhi |
| Address |
Pediatric Intensive Care Unit, Department of Pediatrics, 1st Floor, Sir Ganga Ram Hospital, New Delhi 110060, India.
New Delhi
DELHI
110060
India |
| Phone |
9810098360 |
| Fax |
|
| Email |
anilcritcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Thapa |
| Designation |
DrNB trainee, pediatric critical care |
| Affiliation |
Sir Gangaram hospital ,rajinder nagar , new delhi 110060 |
| Address |
BEHIND ITBP CAMP
DELHI
110060
India |
| Phone |
07051903519 |
| Fax |
|
| Email |
thaparoshni219@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANIL SACHDEV |
| Designation |
Chairman , department of pediatrics |
| Affiliation |
Sir Ganga ram hospital , rajinder , new delhi |
| Address |
Pediatric Intensive Care Unit, 1st Floor, Department of Pediatrics, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi, 110060.
New Delhi
DELHI
110060
India |
| Phone |
9810098360 |
| Fax |
|
| Email |
anilcritcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Ram Institute of Postgraduate Medical Education and Research, New Delhi 110060, India. |
|
|
Primary Sponsor
|
| Name |
Ganga ram institute for postgraduate medical education and research |
| Address |
Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi, India.110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANIL SACHDEV |
Pediatric intensive care unit |
Department of pediatrics, pediatric intensive care unit division ,first floor
New Delhi
DELHI |
9810098360
anilcritcare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee sir gangaram hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: J969||Respiratory failure, unspecified, (3) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HEATED HUMIDIFIED HIGH FLOW NASAL CANNULA |
The preoxygenation will be performed by either HFNC with 100% FiO2 with 2l/kg/min for 4 minutes.The frequency will be decided by randomisation in 1: 1 ratio The patient will be placed in the proper positioning with the neck in the slight extension. The HFNC will be kept in place throughout the procedure from preoxygenation to correct tube placement. Two types of medications will be used in RSI i.e. induction and neuromuscular agents. The inducing agents which will be used are midazolam, ketamine and fentanyl. In cases of shock, ketamine (1mg/kg) as an inducing agent will be used
followed by vecuronium (0.1 mg/kg).In cases of raised intracranial pressure, midazolam(0.1 mg/kg) followed by fentanyl (1ug/kg/dose) followed by vecuronium ( 0.1 mg/kg/dose) will be used . In case of asthma, ketamine (1mg/kg) will be used as an inducing agent followed by vecuronium (0.1mg/kg/dose) as a paralytic agent. After the patient will become apneic, orotracheal intubation will be done. The correct tube placement will be done both clinically and end tidal graph. Video recording of the entire procedure will be done from the time of randomization to connection to ventilator. Spo2 will be recorded at following time intervals from video recording: at initial contact before allocation, after preoxygenation for 4 minutes and lowest saturation during the time period between laryngoscopy and ventilator connection. We will also measure secondary outcomes like difficult intubation, organ failure in first 5 days, adverse events during ETI, time on ventilator, length of stay in PICU, ventilator associated pneumonia |
| Comparator Agent |
NON REBREATHING MASK DURING ENDOTRACHEAL INTUBATION |
preoxygenation will be performed by NRM with 100% oxygen with 16L/min for 4 minutes. The patient will be placed in the proper positioning with the neck in the slight extension. The NRM will be removed after preoxygenation before laryngoscope insertion and free flow oxygen will be provided. Two types of medications will be used in RSI i.e. induction and neuromuscular agents. The inducing agents which will be used are midazolam, ketamine and fentanyl. In cases of shock, ketamine (1mg/kg) as an inducing agent will be used followed by vecuronium (0.1 mg/kg). In cases of raised intracranial pressure, midazolam(0.1mg/kg) followed by fentanyl (1ug/kg/dose) followed by vecuronium (0.1 mg/kg/dose) will be used . In case of asthma, ketamine (1mg/kg) will be used as an inducing agent followed by vecuronium(0.1mg/kg/dose) as a paralytic agent. After the patient will become apneic, orotracheal intubation will be done. The correct tube placement will be done both clinically and end tidal graph. Video recording of the entire procedure will be done from the process of randomization to the ventilator connection. Spo2 will be recorded at following intervals from video recording: at the initial contact before allocation, after preoxygenation for 4 minutes and lowest saturation during the time period between laryngoscopy and ventilator connection. We will also measure secondary outcomes like difficult intubation, organ failure in first 5 days, adverse events during ETI, time on ventilator, length of stay in PICU, ventilator associated pneumonia |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All male and female patients from 1 month to 18 years requiring elective endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Endotracheal intubation for cardiac arrest.
Emergent endotracheal intubation is indicated for conditions such as bradycardia, ventricular fibrillation, and heart block.
Nasopharyngeal obstruction with midline facial deformities of the jaw, nose, and larynx.
Children with chromosomal anomalies.
Children requiring reintubation.
Children unable to achieve saturation greater than 90% after preoxygenation for 4 minutes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lowest saturation |
Lowest oxygen saturation from the start of laryngoscopy insertion until connection to the ventilator. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difficult intubation |
Two failed attempts at direct laryngoscopy & one attempt will be counted as 30 seconds. |
| Time required for intubation |
From the insertion of the laryngoscope to the connection to the ventilator. |
| Organ failure |
During the first five days in the PICU, the assessment will be conducted using the PELOD score. |
| Complications During Endotracheal Intubation |
During endotracheal intubation & the subsequent hour. |
| Time on ventilator |
The duration will be calculated in days, starting from the day of intubation on the mechanical ventilator to the day of extubation. |
| Length of hospital stay |
From the commencement of successful intubation to the point of hospital discharge. |
| Ventilator associated pneumonia |
Achieving a score greater than 6 on the CPIS scale will result in the absolute number of patients being considered. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
22/09/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This is a randomized clinical trial will be conducted in children 1 month to 18 years of age undergoing intubation in a pediatric intensive care .Ninety participants will be randomized to either high flow nasal cannula(HFNC) or non - rebreathing mask(NRM) for preoxygenation prior to intubation. Those randomized to the HFNC will be given heated humidified high flow nasal cannula at a rate of 2l/kg/min ( above 12 kg , add 0.5 l/kg/min with maximum flow of 50l/min ) with 100% fio2 for 4 minutes. In the NRM group, preoxygenation will be done with 15l/min flow and patients will be intubated. The aim is to compare the lowest saturation measured during endotracheal intubation from the insertion of laryngoscope to ventilator connection between patients with HFNC and NRM .These findings may contribute to the better understanding of the newer methods of pre- oxygenation . |