| CTRI Number |
CTRI/2024/07/070232 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess and compare Video Laryngoscopy versus Conventional Laryngoscopy during endotracheal intubation by comparing the time taken for endotracheal intubation in seconds in patients undergoing Surgery under General Anaesthesia |
|
Scientific Title of Study
|
Study to compare time taken to intubate with Videolaryngoscopy versus Conventional laryngoscopy in adult patients undergoing Surgery under General Anesthesia- Prospective randomized study at SMS medical college and attached group of hospital, 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 Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals Jawahar Lal Nehru Marg, Jaipur Jaipur RAJASTHAN 302004 India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and attached Hospitals Jawahar Lal Nehru Marg, Jaipur
RAJASTHAN 302004 India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pankaj Maurya |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and attached Hospitals Jawahar Lal Nehru Marg, Jaipur Jaipur RAJASTHAN 302004 India |
| Phone |
9928019924 |
| Fax |
|
| Email |
mauryapankaj84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals, Jaipur Rajasthan |
| 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 Harpreet Kaur |
Sawai Man Singh Medical College and attached Hospitals |
Department of Anaesthesia, Dhanwantri Block Second Floor Jaipur RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ofiice of Ethics Committee Sawai Man Singh Medical College and Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Laryngoscope |
Time taken for endotracheal intubation in seconds |
| Comparator Agent |
Video Laryngoscope |
Time taken for Endotracheal Intubation in seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients undergoing elective Surgery under General Anaesthesia.
2.Patients having American Society of Anesthesiologist (ASA) physical status I and II..
3.Patients consenting to participate.
4.Patients with Mallampati grade 1 or 2. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patient should not be a part of other study
3.Patient with anticipated difficult intubation
4.Patients having oxygen saturation less than 92% after bag and mask ventilation with 100% oxygen
5.Patient with known risk of Aspiration
6.Emergency surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean Total Intubation time in Seconds
2.Mean Ease of intubation score
3.Mean Modified Cormack Lehane grading
5.Mean Haemodynamic parameters :Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Heart Rate(HR) |
1. Baseline
2. After Induction
3. 1min after induction
4. 5 min after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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)
|
15/07/2024 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Direct
laryngoscopy is most widely used method of oro-tracheal intubation but at times
it could be difficult, and may lead to adverse effect on cardiovascular system.
Video laryngoscopy in contrast provides better visualization of airway making
oro-tracheal intubation easy. In this study we will compare the use of Video
laryngoscope (Group A) versus the macintosh (direct) laryngoscope blade (Group
B) for routine airway management. 88 ASA grade 1 and grade 2
patients between the age of 18 and 60 yrs scheduled for elective laparoscopic
cholecystectomy surgery will be included in the study. Informed written consent
will be taken in the vernacular language. Premedication with injection (Inj)
glycopyrolate 0.2 mg intravenous(i.v) 10 mins before + Inj. midazolam 0.02mg/kg
i.v. 10 mins and (inj) metoclopramide 10mg i.v. 10mins before + injection fentanyl 2mcg/kg i.v.
will be given.
All the patients will be preoxygenated with 100% oxygen through a face mask for
three minutes, then general anesthesia will be induced with intravenous
administration of inj. propofol (2 mg/kg), and inj Succinylcholine (2 mg/kg) Then patients will be randomly divided into 2
groups. Group A (n=44) will be intubated
using video laryngoscope (indirect) and Group B (n=44) will be intubated using
direct laryngoscope (Macintosh) In the group A, an intubating stylet will be
used. The oro-tracheal intubation will be carried out. Time taken for tracheal
intubation procedure, visualization of airway, Haemodynamic parameters (Systolic BP, diastolic BP, mean arterial
pressure, heart rate) will be assessed at numerous intervals as follow: baseline,
after induction of anesthesia, one and five minutes after intubation. |