| CTRI Number |
CTRI/2024/10/074551 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess vertical height from thyroid to mentum for anticipating difficult laryngoscopy. |
|
Scientific Title of Study
|
Evaluation of reliability of thyromental height test as a predictor of difficult laryngoscopy:A prospective observational 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 Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmender Ranga |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9812129334 |
| Fax |
|
| Email |
dharmenderranga2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology & Critical Care, Pt. B. D. Sharma PGIMS, Rohtak-124001, Haryana (India). |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana |
| 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 Jatin Lal |
Pt. B. D. Sharma PGIMS, Rohtak. |
Dept. of Anaesthesiology & Critical Care, 2nd Floor, Modular OT Complex
Rohtak
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, PGIMS/UHS Rohtak |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having American Society Of Anesthesiologists physical classification I-II, scheduled for surgery under general anaesthesia requiring orotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Following patients will be excluded:
-Obvious abnormality of the airway requiring awake tracheal intubation.
-History of difficult intubation.
-Neck swelling or contractures.
-Restriction in mobility of mandible or neck.
-Unstable cervical spine.
-Interincisor distance less than 2.5 cm.
-BMI more than 35 kgm-2.
-Pregnant patients.
-History of radiotherapy for head and neck pathology.
-Need for rapid sequence intubation under cricoid pressure.
-Refusal to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate predictive value of Thyromental Height Test in predicting difficult laryngoscopy as graded by Cormack Lehane grade. |
At the time of Laryngoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate predictive value of Thyromental Height Test in predicting difficult intubation as graded by Intubation Difficulty Scale. |
At the time of endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= "175"
Final Enrollment numbers achieved (India)="175" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 present prospective, non-randomized double blind
observational study will be conducted in the Department of Anaesthesiology and
Critical care, Pt B. D. Sharma, PGIMS, Rohtak, in 175 adult patients (ASA I and
II) of either sex aged 18-65 years, posted for surgery under general
anaesthesia requiring endotracheal intubation. The aim of present study is to
evaluate the reliability of Thyromental Height Test (TMHT) as a predictor of
difficult laryngoscopy. The primary objective of the study is to evaluate
predictive value of TMHT in predicting difficult laryngoscopy as graded by Cormack
Lehane grade. The secondary objective is evaluate predictive value of TMHT in
predicting difficult intubation as graded by Intubation Difficulty Scale. |