| CTRI Number |
CTRI/2024/05/067810 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of different Laryngoscopy positions |
|
Scientific Title of Study
|
Back Up Head Elevated (BUHE) Position vs Sniffing Position for tracheal intubation - A Comparative 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 |
Dr Bhawna Mamtani |
| Designation |
PG Student |
| Affiliation |
Netaji Subhash Chandra Bose Medical College Hospital |
| Address |
Department of Anesthesiology, Netaji Subhash Chandra Bose Medical College Hospital Jabalpur.
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9977400216 |
| Fax |
|
| Email |
bhawnamamtani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Chansoria |
| Designation |
Professor , Head Of Department Emergency Medicine |
| Affiliation |
Netaji Subhash Chandra Bose Medical College Hospital |
| Address |
Department of Emergency Medicine, Netaji Subhash Chandra Bose Medical College Hospital , Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
7049079825 |
| Fax |
|
| Email |
Mayankchansoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Chansoria |
| Designation |
Professor , Head Of Department Emergency Medicine |
| Affiliation |
Netaji Subhash Chandra Bose Medical College Hospital |
| Address |
Department of Emergency Medicine, Netaji Subhash Chandra Bose Medical College Hospital , Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
7049079825 |
| Fax |
|
| Email |
Mayankchansoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Netaji Subhash Chandra Bose Medical College Hospital , Tilwara Road , Medical College Colony , Jabalpur , Madhya Pradesh , India , 482003 |
|
|
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 Mayank Chansoria |
Netaji Subhash Chandra Bose Medical College Hospital Jabalpur |
1st floor , Department of Anesthesiology , Netaji Subhash Chandra Bose Medical College Hospital, Tilwara Road , Doctors Colony , Jabalpur
Jabalpur
MADHYA PRADESH |
7049079825
Mayankchansoria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee NSCB Govt Medical College Jabalpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S099||Unspecified injury of face and head, (2) ICD-10 Condition: S060||Concussion, (3) ICD-10 Condition: S064||Epidural hemorrhage, (4) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (5) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (6) ICD-10 Condition: S068||Other specified intracranial injuries, (7) ICD-10 Condition: V029||Pedestrian injured in collision with two- or three-wheeled motor vehicle, unspecified whether traffic or nontraffic accident, (8) ICD-10 Condition: R060||Dyspnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Back up head elevated (BUHE) position intubation |
This position is achieved by breaking the ER bed or ICU bed at the hip joint and elevating the head of the bed upto 20-25 degrees. To be done for 6 months of the study . |
| Intervention |
Sniffing position intubation |
Head of patient will be raised about 10 cm by folding sheet under the occciput.
Head extension 80-85 degree
Neck flexion 20-25 degree. To be done for 6 months of the study. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients requiring tracheal intubation on the basis of GCS Score and HEAVEN Criteria( hypoxemia , clinical obesity , trauma , mass , swelling , foreign body , or other structural abnormality , vomit, blood fluid , suspected anemia , limited cervical range of motion due o immobilization or arthritis ) |
|
| ExclusionCriteria |
| Details |
Cardiopulmonary arrest , all patients where head and neck manipulation is contraindicated , pregnant females , pediatric patients , patients having hemodynamic instability , patients having hemodynamic instability , patients with a small mouth opening , history of ischemic heart disease , cerebrovascular disease or respiratory disease |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the outcomes and complications in back up head elevated position intubation vs snifffing position intubation |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the time taken for intubation in both positions
2. To compare the no. of intubation attempts needed in both positions
3. To assess the ease of intubation
4. To compare the complications of intubation if any and evaluate the ease of management in both positions |
18 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="30" |
|
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
|
To compare back up head elevated (BUHE) position vs sniffing position for tracheal intubation.- A comparative study. To compare the outcomes and complications in BUHE vs Sniffing position. To compare the time taken for intubation, the no. of intubation attempts needed , assess the ease of intubation and to compare the complications of intubation and evaluate the ease of management in both positions. |