| CTRI Number |
CTRI/2023/10/059185 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| 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
|
Comparison of intubation characteristics using two different instruments in surgeries requiring general anaesthesia |
|
Scientific Title of Study
|
Comparison of intubation characteristics using clearvue video laryngoscope versus macintosh laryngoscope for oral endotracheal intubation in diagnostic direct laryngoscopy and microlaryngeal surgeries requiring general anaesthesia-a randomized interventional study in department of anaesthesia sms medical college jaipur |
| 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 Mamta Sharma |
| Designation |
Senior professore |
| Affiliation |
SMS Medical College and attached Hospitals Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and attached
Hospitals Adarsh Nagar Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
RAJASTHAN
332004
India
Jaipur
RAJASTHAN
332004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior professore |
| Affiliation |
SMS Medical College and attached Hospitals Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and attached
Hospitals Adarsh Nagar Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
RAJASTHAN
332004
India
Jaipur
RAJASTHAN
332004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal singh |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and attached Hospitals |
| Address |
Department of Anesthesiology SMS Medical College and attached
Hospitals Adarsh Nagar Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8949710602 |
| Fax |
|
| Email |
ksingh1412@gmail.vom |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, SMS Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology SMS Medical College and attached Hospitals, Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipu |
| Type of Sponsor |
Government 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 Komal singh |
SMS Medical College and attached Hospitals, Jaipur. |
ENT Operation theatres on 3rd floor
Jaipur
RAJASTHAN |
8949710602
ksingh1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J381||Polyp of vocal cord and larynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Macintosh Direct
Laryngoscope |
COMPARISON OF INTUBATION CHARACTERISTICS USING CLEARVUE
VIDEO LARYNGOSCOPE VERSUS MACINTOSH LARYNGOSCOPE FOR ORAL
ENDOTRACHEAL INTUBATION IN DIAGNOSTIC DIRECT LARYNGOSCOPY
AND MICROLARYNGEAL SURGERIES REQUIRING GENERAL ANAESTHESIA |
| Intervention |
Video
Laryngoscopy for
intubation |
COMPARISON OF INTUBATION CHARACTERISTICS USING CLEARVUE
VIDEO LARYNGOSCOPE VERSUS MACINTOSH LARYNGOSCOPE FOR ORAL
ENDOTRACHEAL INTUBATION IN DIAGNOSTIC DIRECT LARYNGOSCOPY
AND MICROLARYNGEAL SURGERIES REQUIRING GENERAL ANAESTHESIA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex undergoing diagnostic direct laryngoscopy and micro laryngeal surgery
under general anaesthesia.
2.Patients willing to give consent.
3.Age group of 40-70 years.
4.ASA grade I, II &III. |
|
| ExclusionCriteria |
| Details |
•Inter incisor gap <2.5cm.
•Cervical spine pathology.
•Anticipated airway difficulties (Mallampati grade 4 or thyromental distance <6cm)
•BMI >30 Kg/m2
•Cardiorespiratory disease (NYHA class III & IV)
•H/O drug allergy.
•Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean time taken for intubation.
2. Mean intubation difficulty score(IDS).
3. Ease of intubation in both the groups.
4. Mean number of intubation attempts taken in both the groups.
5. Mean heart rate(HR),SBP,DBP,MAP, SpO2.
6. Proportion of cases having airway complications[esophageal intubation, mucosal
bleeding, episodes of desaturation during intubation(SpO2 92%), post extubation
laryngospasm & bronchospasm |
Base Line
After
Induction
At 1 MIN
At 5 MIN
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the haemodynamic parameters (HR,SBP,DBP,MAP, SpOâ‚‚) between the
two groups at different time intervals during intubation.
• To compare the airway complications during endotracheal intubation between the two
groups[esophageal intubation, mucosal bleeding, episodes of desaturation during
intubation(SpO292%) & post extubation laryngospasm and bronchospasm] |
Base Line
After
Induction
At 1 MIN
At 5 MIN |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
06/11/2023 |
| 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="0"
Months="3"
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
|
Difficulty in airway management is a major cause of morbidity and mortality in anaesthetic practice. The ability to identify patients at risk of difficult tracheal intubation is important especially in patients with apparently normal airways. Difficult laryngoscopy (poor glottis visualization) is considered a surrogate indicator of difficult intubation. Preoperative assessment of various anatomic and clinical features helps in identifying potentially difficult laryngoscopy. |