| CTRI Number |
CTRI/2024/03/064295 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Finding the Best Way to Insert Breathing Tubes in Obese Patients: A Randomized Video-Assisted Study" |
|
Scientific Title of Study
|
COMPARISON OF RAMP POSITION AND SNIFFING POSITION FOR VIDEO LARYNGOSCOPE ASSISTED INTUBATION IN MORBIDLY OBESE PATIENTS:A RANDOMISED STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK BISHT |
| Designation |
PG ANAESTHESIA |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
Room no. 304, department of anaesthesia, PGI building, ABVIMS & Dr. RML hospital New Delhi , central Delhi
New Delhi
DELHI
110001
India |
| Phone |
9548693314 |
| Fax |
|
| Email |
abhishekbisht699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEERJA BANERJEE |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
ROOM NO. 301, 3RD FLOOR, DEPARTMENT OF ANAESTHESIA, PGI BUILDING, ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEERJA BANERJEE |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
ROOM NO. 301, 3RD FLOOR, DEPARTMENT OF ANAESTHESIA, PGI BUILDING, ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, ABVIMS and Dr RML Hospital New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [nil] |
|
|
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 Neerja Banerjee |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
ROOM NO. 301, DEPT OF ANAESTHESIA , PGI BUILDING , ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL, BABA KHARAK SINGH MARG , NEAR GURUDWARA BANGLA SAHIB,CONNAUGHT PLACE, NEW DELHI,DELHI 110001 CENTRAL DELHI
New Delhi
DELHI |
9810517575
neerja.banerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,ABVIMS & Dr RML Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation in Sniffing position |
For sniffing position, a 7 cm high pillow will be placed under the head of the patient. |
| Intervention |
Ramped up position |
Ramped up position will be made by using a preformed gel based reusable ramped positioner. Patient will be asked to lie supine on the gel-based ramp on the operating table, so that their external auditory meatus and sternum are at same level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA Class 2 and3. |
|
| ExclusionCriteria |
| Details |
Patients having history of difficult intubation, cervical spine abnormalities or disease, limited mouth opening less than 3 cms and history of neck surgeries or tracheostomy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Time |
Intubation time in first attempt
Intubation time in second attempt
Intubation time in third attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ease of face mask ventilation in Ramp position & Sniffing position as assessed by Face mask ventilation score.
|
Ease of face mask ventilation in Ramp position & Sniffing position within 3 minutes after giving vecuronium.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/03/2024 |
| 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="1"
Months="5"
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
|
The study is a comprehensive exploration of airway management strategies tailored to morbidly obese patients undergoing intubation procedures, with a specific focus on comparing the Ramp position with Sniffing position in the context of video laryngoscope-assisted intubation. While existing evidence supports the effectiveness of the Ramp position in comparison to Sniffing position in direct laryngoscopy, uncertainties persist regarding its applicability in video laryngoscopy. The research aims to bridge this gap by providing a nuanced understanding of the optimal positioning for video-assisted intubation in the challenging demographic of morbidly obese patients. The study’s findings are anticipated to offer practical insights and guidance for anesthesiologists grappling with the intricacies in morbidly obese adult patient population, potentially shaping improved clinical practices and enhancing the overall safety and success of intubation procedures in these individuals. |