| CTRI Number |
CTRI/2024/08/072556 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Airway assessment before surgery and intubation difficulty during surgery
Are they related to each other in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
To determine correlation of change in modified mallampati score with respiration to ultrasound assessment of the airway for ease of intubation |
| 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 Deepak Thapa |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Thapa |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Thapa |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anesthesia and Intensive Care Level 5 D Block GMCH Sector 32. Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Hemal |
Government Medical College and Hospital Chandigarh |
Department of Anaesthesia and Intensive Care level 5 D Block GMCH Sector 32 Chandigarh 160030
Chandigarh
CHANDIGARH |
7082588332
Hemalbhardwaj33242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMCH Chandigarh |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II
2. Age between 18 to 65 years
3. Elective surgery under General anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2.Patients requiring rapid sequence induction
3.Thyroid disease
4.Tracheostomised patients
5.Congenital abnormalities of the airway
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| modified mallampati scores during respiration and ultrasound airway parameters |
Preoperatively in operation theatre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe modified mallampati scores during respiration
2. To observe ultrasonographic parameters
3. To determine the ease of intubation using intubation difficulty scale
4. To observe the perioperative hemodynamics and any adverse events happening during the procedure |
Preinduction, At intubation, 2min, 5min, 10 min |
|
|
Target Sample Size
|
Total Sample Size="241"
Sample Size from India="241"
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)
|
27/08/2024 |
| 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="6"
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
|
Management of the airway is a crucial part during any kind of surgical procedures as well as in emergencies. There are certain predictive parameters using which we can anticipate the difficult airway and manage accordingly. Modified mallampati score is one of the parameters to assess airway. The score can vary on inspiration and expiration thus changing the scores. Airway ultrasound is one of the newer modalities to assess the airway using certain soft tissue dimensions which can direct towards the type of airway. Thus using the above mentioned parameters airway assessment can be done to determine the ease of intubation and also to observe the sensitivity and specificity of the subjective scores such as modified mallampati score. The correlation between the modified mallampati score and airway ultrasound can be used during airway assessment. |