| CTRI Number |
CTRI/2025/07/091744 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation of airway assessment parameter (Thyromental Height Test) for Predicting Difficulty in visualizing vocal cords while inserting endotracheal tube for general anaesthesia in Obstetric Patients |
|
Scientific Title of Study
|
Validation of Thyromental Height test (TMHT) as a predictor of difficult laryngoscope in obstetric patients: a cross-sectional 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 Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no. 731 A, 7th Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no. 731 A, 7th Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Akanksha Rao |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
North East
DELHI
110095
India |
| Phone |
9789716407 |
| Fax |
|
| Email |
raomakanksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB Hospital, Delhi- 110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
UCMS and GTB Hospital, Dilshad Garden, Delhi- 110095 |
| 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 Ruchi Kapoor |
UCMS and GTB Hospital |
2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, Dilshad Garden-110095
North East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Consenting obstetric patients requiring general anaesthesia for caesarian or laparotomy who are beyond 20 weeks of gestation. |
|
| ExclusionCriteria |
| Details |
Following participants are excluded from the study-
1) Patients requiring Fibreoptic intubation
2) Patients with anticipated difficult airway with mouth opening less than 3 cms.
3) Any visible facial, oral or intraoral pathology.
4) Patients with limited neck extension.
5) Patients with cervical spine pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sensitivity of TMHT as a predictor of difficult laryngoscopy in obstetric patients requiring general anaesthesia |
After data collection from all participants of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure the sensitivity of MPG as a predictor of difficult laryngoscopy.
2. Comparison of TMHT versus MPG as predictors of difficult laryngoscopy in same population with respect to: sensitivity, specificity, PPV & NPV.
3. Comparison of sensitivity & specificity of TMHT & MPG as a predictor of difficult intubation.
4. Sensitivity, specificity, PPV & NPV of Thyromental Distance Test as a predictor of difficult laryngoscopy.
5. Sensitivity & specificity of TMD as a predictor of difficult intubation.
6. Prevalence of difficult laryngoscopy in obstetric patients in the current study. |
After data collection from all participants of study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/08/2025 |
| 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="3"
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 Thyromental Height Test (TMHT) is a relatively new pre-operative airway assessment parameter that does not require neck extension and can be done in a neutral position of the head. It has been proven effective in predicting the possibility of difficult laryngoscopy in patients presenting for general anesthesia with less literature available for obstetric population. Hence the primary goal of this study is to assess the accuracy of TMHT for prediction of difficult laryngoscopy in obstetric population. The sample size was calculated using prevelance of difficult laryngoscopy based on study by Sadeh et al., (2025). At 2 tail alternative hypothesis and level of
significance at 5%, the minimum sample size came out to be 128 for the current study. However, due to constraint of time, a minimum of 40 patients will be included in the study for the thesis. |