| CTRI Number |
CTRI/2025/09/094708 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
MAKING BREATHING TUBE PLACEMENT EASIER: COMPARING FLAT AND HALF SITTING POSITION IN ADULT SURGERY PATIENTS USING A CAMERA ASSISTED DEVICE |
|
Scientific Title of Study
|
Comparison of intubating conditions in supine and 25 degree backup position using video laryngoscope in elective surgeries under general anaesthesia-A randomized controlled 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 |
DrPRAKATHI P |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology,Main OT complex,room no 1,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Department of Anaesthesiology,Main OT complex,room no 1,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9159210155 |
| Fax |
|
| Email |
dr.prakathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr INDRAGANDHI J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri venkateshwaraa medical college hospital and research centre, Department of Anaesthesiology,
Main OT complex
13-A, Pondy-Villupuram main road, Ariyur
Sri venkateshwaraa medical college hospital and research centre,
Department of Anaesthesiology,
Main OT complex,
13-A,Pondy-Villupuram main road,
Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903259203 |
| Fax |
|
| Email |
indragandhi1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr INDRAGANDHI J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri venkateshwaraa medical college hospital and research centre,
Department of Anaesthesiology,
Main OT complex,
13-A, Pondy-Villupuram main road, Ariyur
Sri venkateshwaraa medical college hospital and research centre,
Department of Anaesthesiology,
Main OT complex,
13-A, Pondy-Villupuram main road, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6381044144 |
| Fax |
|
| Email |
indragandhi1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateshwaraa medical college hospital and research centre,
Department of Anaesthesiology,
Main OT complex,
13-A, Pondy-Villupuram main road, Ariyur,
Pondicherry,605102
India. |
|
|
Primary Sponsor
|
| Name |
Dr Prakathi P |
| Address |
1st year anaesthesia PG,Department of Anaesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre,
13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry, India,
605102. |
| Type of Sponsor |
Private medical college |
|
|
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 PRAKATHI P |
sri Venkateshwara Medical College Hospital and research centre |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY |
9159210155
dr.prakathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee ( Human Studies) |
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 |
intubation in general anaesthesia using video laryngoscope |
comparison of intubating condition in two different position supine and 25 degree backup position in elective surgeries under general anaesthesia |
| Intervention |
intubation with video laryngoscopy |
intubation with video laryngoscopy in elective surgeries requiring general anaesthesia procedure takes about 5-15mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
MMG I ,II and III
BMI less than 34.9Kg per m2 |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Morbid obese (BMI more than 35 Kg per m2).
3.Previous oral cavity surgeries.
4.Anticipated difficult airway.
5.Pre-existing tracheal or laryngeal pathology.
6.Patient requiring rapid sequence intubation.
7.Pregnant females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Intubation Difficulty Score (mIDS):
This score evaluates the overall ease or difficulty of intubation in two different position. It considers:
•Number of attempts
•Number of operators
•Alternative techniques required as
Lifting force needed, External laryngeal manipulation (ELM),Vocal cord position, Percentage of glottis, opening (POGO) score |
At intubation : 0min,2min,5min
record each component of mIDS during the actual intubation attempt. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubation time
Video laryngoscope handling time
Recording of peri-intubation complications (e.g., desaturation, bronchospasm, oropharyngeal trauma, esophageal intubation) |
1.Intubation time: 0mins,1min, 2min measured during the intubation attempt insertion of the video-laryngoscope blade between the teeth to first effective ventilation confirmed by capnography
2.Video laryngoscope handling time: 0mins (during intubation event)
3.Peri-intubation complications during attempt & within 0–2 minutes after intubation (desaturation, esophageal intubation, trauma, bronchospasm).
|
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
24/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/09/2025 |
| 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
|
Airway management is a cornerstone of anaesthesia, with endotracheal intubation being a critical skill. Traditionally, the “sniffing position” has been considered optimal for direct laryngoscopy, but with the advent of video laryngoscopes (VLS), patient positioning may influence visualization and intubation success differently. The 25° back-up position has been suggested to improve pre-oxygenation, laryngeal view, and ease of intubation, though evidence comparing it to the supine position using VLS remains limited.This randomized controlled, double-blinded trial is designed to compare intubating conditions in the supine and 25° back-up positions using a video laryngoscope in adult patients undergoing elective surgeries under general anaesthesia. A total of 74 ASA I–II patients aged 18–65 years will be randomized into two groups: Group A (supine) and Group B (25° back-up).The primary outcome is the ease of intubation assessed by the Modified Intubation Difficulty Score (mIDS). Secondary outcomes include intubation time, video laryngoscope handling time, and peri-intubation complications.By systematically evaluating intubation performance across these positions, the study aims to determine whether the 25° back-up position offers a clinical advantage over the conventional supine posture, thereby guiding optimal positioning strategies for video laryngoscopy in routine anaesthesia practice. |