| CTRI Number |
CTRI/2024/06/069663 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two instruments used for inserting Breathing Tubes: Modern (Video) laryngoscope vs. Traditional (Macintosh) Laryngoscope |
|
Scientific Title of Study
|
Comparison between video laryngoscope and macintosh laryngoscope for intubating difficult airways |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santhiya C |
| Designation |
Post graduate Resident |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Department of Anaesthesiology,
First floor, Operation theatre complex, Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8248783645 |
| Fax |
|
| Email |
drsanthiyachandran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Cheran |
| Designation |
Professor and Medical Superintendent |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Department of Anaesthesiology, First floor, Operation theatre complex, Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443144652 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santhiya C |
| Designation |
Post graduate Resident |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Department of Anaesthesiology, First floor, Operation theatre complex, Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8248783645 |
| Fax |
|
| Email |
drsanthiyachandran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College |
|
|
Primary Sponsor
|
| Name |
Santhiya C |
| Address |
Department of Anaesthesiology, First floor, Operation theatre complex, Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal, Pondicherry |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Santhiya C |
Vinayaka Missions Medical College Hospital |
Department of Anaesthesiology, First floor, Operation theatre complex, Vinayaka Missions Medical College, Keezhakasakudy medu, kottucherry post, Karaikal
Karaikal
PONDICHERRY |
8242783645
drsanthiyachandran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
Macintosh Laryngoscope |
Using Macintosh Laryngoscope for intubation, duration minimum 15seconds to maximum 3 minutes, frequency only once |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Video Laryngoscope |
Using Video Laryngoscope for intubation, duration minimum 15seconds to maximum 3 minutes, frequency only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients under ASA I and II
Mallampati class 3 and 4
|
|
| ExclusionCriteria |
| Details |
Serious cardiovascular abnormality
Patients with Vocal cord polyp, Cervical spine disorders, Supra glottic carcinoma
Anesthesia requiring rapid sequence induction
Limited mouth opening
Limited neck extension
Obesity: BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for the laryngoscope tip passing incisors to initial appearance of capnography |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts,
Rate of successful intubation,
Optimization maneuvers used,
Airway injuries,
Ease of intubation |
At baseline, 1day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study compares modern (Video) laryngoscopes, which use a camera for better visibility during difficult intubations, with traditional (Macintosh) laryngoscopes that rely on direct sight.
This study aims to identify which laryngoscope type is faster and more effective in challenging intubation scenarios.
This study will help in improving intubation success rates by determining which tool is more efficient.
|