| CTRI Number |
CTRI/2025/06/089052 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study To Asses The Efficiency Of between The Fingers Grip With The Conventional Pen Holding Grip To Holding Endotracheal Tube For orotracheal Intubation Using C Mac Videolaryngoscope |
|
Scientific Title of Study
|
A Prospective Comparative Study To Asses The Efficacy Of between The Fingers Grip With The Conventional Pen Holding Grip To Hold An endotracheal Tube For orotracheal Intubation Using C Mac Videolaryngoscope |
| 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 NANDINI CV |
| Designation |
Associate professor |
| Affiliation |
Dr. B.R. Ambedkar Medical College |
| Address |
OT Complex, Department of Anaesthesia, Dr B R Ambedkar medical college and Hospital no 24, shampura main road , kadugondanahalli Bengaluru
Bangalore
KARNATAKA
India
Bangalore
KARNATAKA
560045
India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NANDINI CV |
| Designation |
Associate professor |
| Affiliation |
Dr. B.R. Ambedkar Medical College |
| Address |
OT complex,department of anaesthesia, Dr B R Ambedkar medical college andhospital no 24, shampura main road , kadugondanahalli bengaluru
Bangalore
KARNATAKA
India
KARNATAKA
560045
India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUVINA |
| Designation |
Associate professor |
| Affiliation |
Dr. B.R. Ambedkar Medical College |
| Address |
OT Complex, Department of Anaesthesia, Dr B R Ambedkar Medical College and Hospital no 24, shampura main road , kadugondanahalli bengaluru
Bangalore
KARNATAKA
India
KARNATAKA
560045
India |
| Phone |
6366279888 |
| Fax |
|
| Email |
suvi11492@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr B R Ambedkar Medical college |
| Address |
DR B R Ambedkar medical college, No 24, Near tannery road, Gandhinagar,shampura main road kadugondanahalli, Bengaluru-560045
karnataka
India |
| 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 NANDINI CV |
Dr BR Ambedkarmedical college andhospital |
Major OT Complex, 1st floor,Shampura mainroadK.G.Halli 560045
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09535024072
nandinivraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE |
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 |
patients undergoing orotracheal intubation using c macvideolaryngoscope by modified finger holding technique for holding enndotracheal tube |
Total duration 6 months.Patients undergoing orotracheal intubation using c macvideolaryngoscope by modified finger holding technique for holding enndotracheal tube |
| Comparator Agent |
Patients undergoing orotrachealintubation using c macvideolaryngoscope by conventionalpending holding method for endotrachealintubation |
Patients undergoing orotrachealintubation using c macvideolaryngoscope by conventionalpending holding method for endotrachealintubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age - 18 to 60 years and American Society of Anaesthesiologists physical status(ASA- PS) I and II patients.
2.Patients with Mallampati grades (MP) 1,2, 3 |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate in the study, Patients with cormack Lehane (CL) grades 3b ,4
2.patients with an anticipated difficult airway, history of difficult airway in previousdocuments, head and neck pathology, and haemodynamic instability.
3. patients with cervical spine instability , reactive airway , gastric reflux , cerebralhemorrhage will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To measure time required for endotracheal intubation for each grip using CMAC videolaryngoscopy
2.To compare the requirement of external assistance in the form of thebackward upward rightward pressure manoeuvre (BURP) to performendotracheal intubation |
from base line to30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparing the number of attempts for endotrachealintubation for each grip and use of external aids such asbougie and stylet
2.The variations in the haemodynamic parameters heart rate(HR) and mean arterial pressure (MAP)) in the two groups. |
Time from enotracheal intubation to30 min of intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/04/2026 |
| 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="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
|
It has been documented that time taken for intubation is usually longer especially with angulatedblade as easy visualization of glottis does not guarantee easy passage of ET tube into larynx andthis is aptly termed as “Laryngoscopy paradox". Modified grip i.e., between the finger method of endotracheal tube holding allowed the operator tochange the curvature of the ETT as it neared the glottic opening in a dynamic fashion duringlaryngoscopy thus, the tip can be manoeuvred forward and anteriorly, providing better control andalignment than fixed curvature in the conventional pen holding method of endotracheal tube. In this study we aim to compare, modified between-the- finger grip with that of conventional pen-holding method of endotracheal tube for orotracheal intubation using C -MAC Video laryngoscope. |