| CTRI Number |
CTRI/2025/04/084306 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Heart rate and blood pressure during insertion of endotracheal tube with two different CMAc video laryngoscopes blades in hypertensive patients. |
|
Scientific Title of Study
|
Comparison of hemodynamic effects of orotracheal intubation using McIntosh blade CMAC versus D blade CMAC Video-laryngoscope in hypertensive patients with normal airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishant Patel |
| Designation |
Associate professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room no 5013
Teaching Block
Department of Anaesthesia
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishant Patel |
| Designation |
Associate professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room no 5013
Teaching Block
Department of Anaesthesia
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishant Patel |
| Designation |
Associate professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room no 5013
Teaching Block
Department of Anaesthesia
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 5007 , Teaching block , Department of Anesthesiology , AIIMS,New Delhi , India , PIN code 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS, New Delhi
PIN 110029 |
| 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 |
| Nishant Patel |
AIIMS,New Delhi |
Main Operation Theatres,
Department of Anesthesiology
South
DELHI |
8510955882
pateldrnishant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D - D-Blade C-MAC video-laryngoscope group |
Laryngoscopy and Intubation with D Blade CMAC video laryngoscope
Duration - 8 min after intubation
Just before intubation (T1), again all values will be noted. The endotracheal tubes size of 7.0 and 7.5 mm ID for female and male patients respectively will be taken. Also, size 3 and 4 C-MAC Macintosh and D blades for female and male patients respectively will be used. Intubation stylet will be used for all the intubations. Time to intubation will be started as laryngoscope blade tip passes the incisors till end tidal carbon dioxide are noted on capnography. All intubations will be performed by a consultant anaesthesiologist having experience of at least 20 times usage of C-MAC laryngoscope Mcintosh and D blade each. Failure to intubate in first attempt will be dealt with according to standard failed intubation guidelines, and patient will be excluded from study. Succeeding intubation, all hemodynamic parameters will be recorded at immediately after intubation (T3), 1minute (T4), 3 minute (T5) and 5minute (T6) intervals after intubation. The intubation times and other outcome parameters will be noted by an independent observer who is unaware of the study methodology. Ease of intubation will be measured from 0 to 10 . The intraoperative and post operative care of the patient will be according to standard institutional protocols.
|
| Comparator Agent |
Group M - Macintosh blade C-MAC video-laryngoscope group |
Laryngoscopy and Intubation with D Blade CMAC video laryngoscope
Duration - 8 min after intubation
Just before intubation (T1), again all values will be noted. The endotracheal tubes size of 7.0 and 7.5 mm ID for female and male patients respectively will be taken. Also, size 3 and 4 C-MAC Macintosh and D blades for female and male patients respectively will be used. Intubation stylet will be used for all the intubations. Time to intubation will be started as laryngoscope blade tip passes the incisors till end tidal carbon dioxide are noted on capnography. All intubations will be performed by a consultant anaesthesiologist having experience of at least 20 times usage of C-MAC laryngoscope Mcintosh and D blade each. Failure to intubate in first attempt will be dealt with according to standard failed intubation guidelines, and patient will be excluded from study. Succeeding intubation, all hemodynamic parameters will be recorded at immediately after intubation (T3), 1minute (T4), 3 minute (T5) and 5minute (T6) intervals after intubation. The intubation times and other outcome parameters will be noted by an independent observer who is unaware of the study methodology. Ease of intubation will be measured from 0 to 10 (Reference?). The intraoperative and post operative care of the patient will be according to standard institutional protocols. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Normal airway
History of hypertension
ASA Status II
Elective surgery requiring orotracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA III and above
Cardiovascular disease- Heart failure, Ischemic heart disease, valvular heart disease
Atrioventricular block in ECG
Emergency surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the heart rate and blood pressure variation between laryngoscopy with C-MAC Macintosh blade and C-MAC D blade videolaryngoscopy. |
baseline, just before intubation, immediately after intubation, 1 minute, 3 minutes and 5 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare C-MAC Macintosh blade & C-MAC D blade videolaryngoscopy in terms of-
The intubation time
First attempt success rate
POGO scoring of glottic view
Adverse events during intubation
Ease of intubation score
|
baseline, just before intubation, immediately after intubation, 1 minute, 3 minutes & 5 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
08/09/2025 |
| Date of First Enrollment (Global) |
15/04/2025 |
| Date of Study Completion (Global) |
08/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There has been prevalent use of video laryngoscopes in modern anaesthesia practice. C-MAC® is one of the commonly used devices for securing airway for general anaesthesia. C-MAC has been shown to be better than conventional direct laryngoscopy for securing airway, . The D-blade C-MAC due to its more anatomically compatible shape may require lesser force during laryngoscopy. The rationale behind this study is the lacunae in the knowledge regarding the choice of blade between C-MAC Macintosh blade and C-MAC D blade for hypertensive patients undergoing general anaesthesia. The comparison will help us to find out if D blade C- MAC has any superiority over Macintosh blade in terms of hemodynamic adverse effects. |