| CTRI Number |
CTRI/2025/12/099868 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using Nasal Oxygen to Maintain Safe Oxygen Levels During Intubation in Children with Cleft Lip and Palate Surgery |
|
Scientific Title of Study
|
Effect of Apneic Oxygenation via Nasal Cannula on Oxygen Reserve Index during Laryngoscopy and Intubation in Pediatric Cleft Lip and Palate Surgery: A Randomized Controlled Double blind 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 |
Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Departement ofanesthesia, Level-6 medical college
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
09811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Departement ofanesthesia, Level-6 medical college
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
09811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Departement ofanesthesia, Level-6 medical college
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
09811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, district dehradun, uttarakhand, India, pin 24903 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Reserach cell, All India Institute of Medical sciences, Rishikesh, District Dehradun,uttarakhand, India Pin 249203 |
| 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 |
| Priyanka Gupta |
All India Institute of Medical Sciences, Rishikesh |
Department of anesthesia, level 6
Dehradun
UTTARANCHAL |
9811894899
drpriyankagupta84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
apneic oxygenation via nasal cannula during laryngoscopy and intubation |
following mask ventilation children will be provided apneic oxygenation via nasal cannuala, oxygen will be given at the rate of 2-4 litrese/min for for the duration of laryngoscopy and intubation approximtely 30 seconds to 45 seconds |
| Comparator Agent |
children in control group will be attached with the nasal cannula however apneic oxygenation will not be done during laryngoscopy and intubation |
only nasal cannula will be attached for blinding purpose during the duration of laryngoscopy and intubation approximately 30 to 45 seconds |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
all the children of of 3 months to 24 months scheduled for elective surgery to repair cleft lip and/or palate under general anesthesia with tracheal intubation |
|
| ExclusionCriteria |
| Details |
following children will be excluded:
1.Known congenital cardiac defects.
2.Significant syndromic associations.
3.Anemia
4.Known nasal obstruction.
5.Significant pulmonary or respiratory disease.
6.Recent upper or lower respiratory tract infection (within 2 weeks).
7.Anticipated difficult airway
8.Parental/legal guardian’s refusal to participate in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of apneic oxygenation on oxygen reserve index |
measurement of oxygen reserve index at baseline, 1 minute after induction, 3 minutes after induction, at starts of laryngoscopy and at intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the first-pass success rate of intubation between children receiving apneic oxygenation & those in the control group. |
5 minutes after induction |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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)
|
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
|
this randomized prospective study evaluates efficacy of apneic oxygenation in children undergoing cleft lip-palate surgery, which is measured by oxygenation reserve index. the apneic oxygenation will be given by nasal cannula, the oxygen flow will be given according to body weight. the other secondary outcome would be incidences of desaturation during laryngoscopy and intubation, rate of first pass successful intubation and correlation of peripheral oxygenation with oxygen reserve index |