| CTRI Number |
CTRI/2025/09/095465 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing 2 techniques for securing a tube in trachea for giving anaesthesia in children |
|
Scientific Title of Study
|
Comparison of Supraglottic assisted fiberoptic intubation (SAFI) with video assisted fiberoptic intubation (VAFI) in children requiring endotracheal intubation for elective surgery among trainees: SAVIO 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 |
Divya Jain |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Jain |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
CHANDIGARH
160012
India |
| Phone |
09855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Jain |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
CHANDIGARH
160012
India |
| Phone |
09855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of medical education and research, Chandigarh, 160012, India |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of anaesthesia, 4th floor, Nehru Hospital, PGIMER, Sector 12,Chandigarh, 160012, India |
| 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 |
| Divya Jain |
Postgraduate Institute of medical education and research |
OT complex, 6th Floor, APC Building, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
09855900171
Jaindivya77@rediffmail.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 |
| Comparator Agent |
SAFI (Supraglottic assisted fiberoptic intubation) |
Patients will undergo endotracheal intubation with Supraglottic assisted fiberoptic intubation 4 minutes after induction of anaesthesia. |
| Intervention |
VAFI:Videolaryngoscope assisted fiberoptic intubation |
Patients will undergo endotracheal intubation with Videolaryngoscope assisted fiberoptic intubation 4 minutes after induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients of ASA status I and II in the age range of 1month -2 years of either gender
Requiring endotracheal intubation for undergoing elective surgery
|
|
| ExclusionCriteria |
| Details |
Patient’s parental Refusal
Anticipated Difficult Airway
Tonsillar/adenoid hyperplasia
Congenital airway anomalies
Coagulation defects
History of a recent upper respiratory tract infection or significant pulmonary disease
• Children requiring RSI (Full stomach, Active GERD)
• Severe Obstructive sleep apnea
• ASA Physical status 3 or higher
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time taken to perform tracheal intubation |
1 second after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First pass success rate |
30 seconds At the end of intubation |
| glottic visualization using Cormack & Lehane glottic score (CL) |
30 seconds after laryngoscopy |
| intubation difficulty score |
30 seconds after intubation |
| Complications |
1 hour after the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="2"
Months="0"
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
|
Children in the age group of 1 month to 2 years undergoing surgery would be enrolled. They would be divided into 2 groups undergoing fiberoptic intubation using either supraglottic airway or a videolaryngoscope. Time take to intubate would be recorded as the primary outcome. |