| CTRI Number |
CTRI/2024/08/073152 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the Ratio of Neck Size to Thyroid-Chin Distance as a Predictor of Difficult Breathing Tube Insertion in Overweight Male Versus Female Patients |
|
Scientific Title of Study
|
Evaluation Of Ratio Of Neck Circumference To Thyromental Distance As Predictor Of Difficult Intubation In Obese Male Versus Female Patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Anupam21 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUPAM YADAV |
| Designation |
PG ANAESTHESIA |
| Affiliation |
ABVIMS and Dr RML Hospital ​New Delhi – 110001 |
| Address |
Room No. 1503B Block 15th Floor Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi-110001
Central
DELHI
110001
India |
| Phone |
7906576741 |
| Fax |
|
| Email |
doc.ay1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MOHANDEEP KAUR |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS and Dr RML Hospital ​New Delhi – 110001 |
| Address |
Room No511 5th Floor Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi-110001
Central
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohandeep Kaur |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital ​New Delhi – 110001 |
| Address |
Room no 511 ​Department of Anaesthesiology
​ABVIMS and Dr RML Hospital
​New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR RML HOSPITAL DELHI INDIA 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 Anupam yadav |
ABVIMS and Dr RML Hospital |
3rd floor Department Of Anaesthesia ABVIMS AND DR RML HOSPITAL
Central DELHI
Central
DELHI |
7906576741
doc.ay1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Name of Committee Institutional Ethics Committee ABVIMS and 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, (2) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60years
ASA grade I and II
BMI more than 30 kg per meter square |
|
| ExclusionCriteria |
| Details |
Trauma and tumour or deformity of upper airway
Difficult mouth opening with interincisor gap of less than three cm
Fracture and deformity of cervical spine
Patient with thyroid and neck swelling |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Circumference
Thyromental Distance |
Neck circumference and thyromental distance are measured preoperatively fifteen minutes before |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.​Modified Mallampati score
2. ​Requirement of any other airway device like stylet or bougie
3.​Requirement of any external laryngeal manoeuvre.
4. ​Requirement of Change of anaesthetist.
5. ​Number of attempts of intubation.
6.​Time taken for intubation.
|
From preoxygenation to endotracheal tube placement |
|
|
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)
|
09/09/2024 |
| 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="2" |
|
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
|
This is a cohort observational study to evaluate difficult intubation in obese male verses female by measuring neck circumference to thryromental distance ratio in obese patients undergoing elective surgery under general anaesthesia. This study has total sample size of 60 obese male and female patients. Present study focuses on a novel preoperative predictor—the ratio of neck circumference(NC) to distance (TMD). This is non-invasive bedside test, requiring minimal time and no special equipment, exhibits superior statistical significance compared to existing indices. Addressing the challenges of maintaining airway patency in obese patients in both the genders. There is very less studies done separately in obese male verses female patients. There is paucity of literature evaluating ratio of Neck circumference to Thyromental distance as predictor of difficult intubation in obese male verses female patients. |