| CTRI Number |
CTRI/2024/03/064929 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is based on the glottis view in different positions like sniffing position and 25 degree backup position, during intubation in patient undergoing general anaesthesia. |
|
Scientific Title of Study
|
A Comparative Study of Glottic Visualisation and ease of intubation between sniffing position and 25 degree backup position in adult patients undergoing 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 |
Abhirami G |
| Designation |
Post graduate student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .
Bangalore KARNATAKA 560002 India |
| Phone |
8904215031 |
| Fax |
|
| Email |
Abhiramighyr13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ramachandraiah R |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .
Bangalore KARNATAKA 560002 India |
| Phone |
8904215031 |
| Fax |
|
| Email |
ramachandraiah090@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ramachandraiah R |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .
Bangalore KARNATAKA 560002 India |
| Phone |
8904215031 |
| Fax |
|
| Email |
ramachandraiah090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Abhirami G |
| Address |
Post graduate, Department of Anaesthesiology, Bangalore medical college and research institute, K R Market, Bangalore 560002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Abhirami G |
Bangalore Medical College and Research Institute |
Major operation theatre , 3rd floor , MPB building, Victoria hospital, Bangalore, Karnataka Bangalore KARNATAKA |
8904215031
Abhiramighyr13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee BMCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing the Glottic view and ease of intubation between sniffing and 25 degree backup position inducing intubation in adult patients undergoing general anaesthesia |
Sniffing position being the stand position used during intubation which is compared with 25 degree backup position for glottis view and ease of intubation |
| Comparator Agent |
Comparing the Glottic view and ease of intubation between sniffing position and 25 degree backup position |
Study group divided into two groups , group 1 intubated in sniffing position and group 2 intubated in 25 degree backup position, the glottis view and ease of intubation compared as per Cormack Lahane grading and intubation difficult scale respectively . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who are giving consent for participating in the study undergoing general Anaesthesia |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway like bucked teeth , restricted neck movements, inter incisor gap less than 35mm , limited mandibukar movement, risk of aspiration, pregnant women, obese patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glottis view as per Cormack Lahane grading |
During direct laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation as per Intubation Difficult Scale |
During Intubation |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
07/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="2" Days="3" |
|
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
|
After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study, after obtaining informed consent will be included in the study and divided into two groups using computer generated randomization sequence. 1.Group I = Sniffing position 2.Group II = 25â—¦ backup position All patients evaluated thoroughly in preoperative period for Mallampati grading, thyromental distance, Inter-incisor gap, Neck movements, Mandibular movement, Pharyngeal pathology. All patients kept nil per oral overnight and premedicated with alprazolam 0.5mg the previous night of surgery. After arriving at pre operative room IV line secured and fluids connected. In operation theater Non-invasive blood pressure, Plethysmography, Electrocardiography connected. Before induction in Group I (sniffing position) patients 8cm head ring placed under head in supine position. All patients will be premedicated, preoxygenated, induced as per institutional protocol. At time of Direct laryngoscopy using size 3 Macintosh blade, in Group I patients head will be extended at atlanto-occipital joint maximally, in Group II patients 25-degree backup position will be given at torso at level of hip. Glottic visualization during laryngoscopy assessed by Cormack and Lehane grading and Ease of intubation will be assessed by Intubation Difficulty Scale (IDS) |