| CTRI Number |
CTRI/2023/09/057575 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the changes in perfusion index while performing endotracheal intubation using Macintosh or McCoy or video laryngoscope in patients who undergo elective surgery ABD requiring general anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of perfusion index to endotracheal intubation with Macintosh, McCoy and video laryngoscope in patients undergoing elective surgery under general anaesthesia |
| 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 Dipali Taneja |
| Designation |
Specialist Grade 1 |
| Affiliation |
Deen Dayal Upadhyay Hospital, New Delhi |
| Address |
Dept. of Anaesthesiology, Deen Dayal Upadhyay Hospital, Harinagar, New Delhi, West Delhi
West
DELHI
110064
India |
| Phone |
9718990125 |
| Fax |
|
| Email |
taneja.sandeep13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Taneja |
| Designation |
Specialist Grade 1 |
| Affiliation |
Deen Dayal Upadhyay Hospital, New Delhi |
| Address |
Dept. of Anaesthesiology, Deen Dayal Upadhyay Hospital, Harinagar, New Delhi, West Delhi
West
DELHI
110064
India |
| Phone |
9718990125 |
| Fax |
|
| Email |
taneja.sandeep13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Taneja |
| Designation |
Specialist Grade 1 |
| Affiliation |
Deen Dayal Upadhyay Hospital, New Delhi |
| Address |
Dept. of Anaesthesiology, Deen Dayal Upadhyay Hospital, Harinagar, New Delhi, West Delhi
West
DELHI
110064
India |
| Phone |
9718990125 |
| Fax |
|
| Email |
taneja.sandeep13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deen Dayal Upadhyay Hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Deen Dayal Upadhyay Hospital
Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shrikanta |
Deen Dayal Upadhyay Hospital New Delhi |
Harinagar
Nanakpura
Pin 110064
New Delhi
West
DELHI |
9113633142
drshrikantab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee - Deen Dayal Upadhyay Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Other intraoperative and post procedural complications and hepatic and gastrointestinal surgical disease |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscopy |
Baseline PI and haemodynamic variables will be noted, after induction with inj.propofol (2mg/kg), inj. fentanyl (2mcg/kg) and inj. Vecuronium (0.1mg/kg) iv loading doses, laryngoscopy will be done with either Macintosh, McCoy or video laryngoscope and endotracheal intubation will be done. |
| Comparator Agent |
Perfusion index and haemodynamic variables will be noted and compared when laryngoscopy and endotracheal intubation with either Macintosh, McCoy or video laryngoscope. |
Perfusion index and haemodynamic variables will be noted at Baseline, just before induction, immediately before laryngoscopy, immediate after laryngoscopy and intubation, and 2,4,6,8,10 minutes after intubation with either Macintosh, McCoy or video laryngoscope and results will be compared.
Also correlation between perfusion induction and haemodynamic variables will be evaluated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients scheduled for elective surgery under general anaesthesia.
2) ASA class 1 and 2.
3) Body mass index (BMI) between 18.5 and 25kg/m2.
4) Mallampati class 1 and 2. |
|
| ExclusionCriteria |
| Details |
1) Anticipated difficult intubation.
2) Patients undergoing head and neck surgery.
3) Patients with hepatic, renal, cardiorespiratory insufficiency or severe infection.
4) Pregnant women. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in perfusion index to endotracheal intubation either with Macintosh, McCoy or Video laryngoscope in patients undergoing elective surgery under general anaesthesia. |
Baseline, just before induction, immediately before laryngoscopy, immediately after laryngoscopy and intubation, and 2,4,6,8,10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare responses of the non hemodynamic variables (HR, SBP,DBP, MAP) to endotracheal intubation with either Macintosh, McCoy or video laryngoscope.
2) To investigate the correlation between perfusion index and non invasive hemodynamic variables to endotracheal intubation with either Macintosh, McCoy or video laryngoscope. |
Baseline, just before induction, immediately before laryngoscopy, immediately after laryngoscopy and intubation, and 2,4,6,8,10 minutes after intubation. |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/09/2023 |
| 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="5"
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 is a prospective randomised comparative study to compare the changes in perfusion index to endotracheal intubation either with Macintosh, McCoy or video laryngoscope in patients undergoing elective surgery under general anaesthesia. Here patients will be allocated into three groups by block randomisation. Patients of a particular group will be undergoing laryngoscopy and intubation by using a particular type of laryngoscope. Changes in Perfusion index and hemodynamic variables will be noted at baseline, just before induction, immediately before laryngoscopy, immediately after laryngoscopy and intubation, and 2,4,6,8,10 minutes after intubation. Correlation between perfusion index and haemodynamic variables will be investigated. The study will evaluate which among the laryngoscopes will show better perfusion index and lesser haemodynamic response. |