| CTRI Number |
CTRI/2024/06/068634 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational Study for Predicting Difficult Tube Placement by Airway Assessment Tests in Adults: Which Airway Assessment Test is Most Accurate? |
|
Scientific Title of Study
|
Prospective evaluation of airway assessment tests to predict difficult endotracheal intubation in adults: 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 |
Shrawan |
| Designation |
Postgraduate Student |
| Affiliation |
Yenepoya School of Allied Health Sciences ,Yenepoya (Deemed to be University) |
| Address |
Department of Anaesthesia and OT Technology
Yenepoya School of Allied Health Sciences
Yenepoya (Deemed to be University)
Deralakatte,
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9606411399 |
| Fax |
|
| Email |
shrawanacharya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aejaz Ahamed Z |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College ,Yenepoya(Deemed to be University) |
| Address |
Department of Anesthesiology
Yenepoya Medical College
Yenepoya(Deemed to be University)
Deralakatte,
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8904062674 |
| Fax |
|
| Email |
aejazah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aejaz Ahamed Z |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College ,Yenepoya(Deemed to be University) |
| Address |
Departement of Anaesthesiology
Yenepoya Medical College
Yenepoya(Deemed to be University)
Deralakatte,
Mangalore
KARNATAKA
575018
India |
| Phone |
8904062674 |
| Fax |
|
| Email |
aejazah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Yenepoya (Deemed to be University), Deralakatte, Mangalore, Dakshina kannada, Karnataka, India-575018 |
|
|
Primary Sponsor
|
| Name |
Shrawan |
| Address |
Yenepoya School of Allied Health Sciences
Yenepoya (Deemed to be University)
Mudipu Campus,
Near Surya Tech Park Kayargoli,
Kurnad POst, Bantwal 574153 |
| 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 Aejaz Ahamed Z |
Yenepoya Medical College Hospital |
Preoperative ward and Operation theatre complex, 6th floor and 3rd floor, Department of Anaesthesiology, Deralakatte, Mangalore 575018
Dakshina Kannada
KARNATAKA |
8904062674
aejazah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee -1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing Elective surgery under general anaesthesia,With ASA physical status I and II. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anaesthesiologists) Physical status I and II
patients, aged between 18 - 60 years posted for elective surgery under
general anaesthesia |
|
| ExclusionCriteria |
| Details |
Head and neck surgeries including malignancies and trauma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To systematically evaluate and compare the efficacy of Upper Lip Bite Test (ULBT) and Ratio of Height To Thyromental Distance (RHTMD) in predicting difficult endotracheal intubation with other airway assessments. efficacy will be assessed based on cormach and Lehne grading |
Preoperative airway assessments will be done initially in the pre-operative ward which will predict the difficulty of intubation (5-6min)
The Anaesthesiologist will do intraoperatively Laryngoscopy to assess Cormach and Lehne grading(15min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the efficacy of the Atlanto-occipital Joint Movement Test (AOJMT) in predicting difficult endotracheal intubation. the efficacy will be based on Cormack & Lehane grading |
Preoperative airway assessments will be done initially in the pre-operative ward which will predict the difficulty of intubation (5-6min)
Intraoperatively Laryngoscopy will be done by the Anaesthesiologist to assess the cormack & lehane grading (15min) |
|
|
Target Sample Size
|
Total Sample Size="223"
Sample Size from India="223"
Final Enrollment numbers achieved (Total)= "223"
Final Enrollment numbers achieved (India)="223" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2024 |
| Date of Study Completion (India) |
07/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
In this study "PROSPECTIVE EVALUATION OF AIRWAY ASSESSMENT TESTS TO PREDICT DIFFICULT ENDOTRACHEAL INTUBATION IN ADULTS: OBSERVATIONAL STUDY " is a prospective observational study that aims to evaluate the Upper Lip Bite Test (ULBT) and Ratio of Height to Thyromental Distance (RHTMD) in comparison with various airway assessment tests for predicting difficult endotracheal intubation in adults undergoing general anaesthesia. This study will include 223 participants, and the data will be analyzed based on sensitivity, specificity, positive predictive value, and negative predictive value. The study’s primary objective is to assess the effectiveness of ULBT and RHTMD in predicting difficult endotracheal intubation. And secondary objective is to explore the efficacy of the Atlanto-occipital Joint Movement Test (AOJMT) in predicting difficult endotracheal intubation. Once the patient is shifted to the pre-operative ward, preoperative airway assessment tests such as inter-incisor gap (IIG), Mallampati grading (MPG), Head and Neck Movement (HNM), Horizontal Length of Mandible (HLM), Sternomental distance (SMD), Upper Lip Bite Test (ULBT), Ratio of Height to Thyromental Distance (RHTMD), Atlanto-occipital Joint Movement Test (AOJMT) and Thyromental Distance (TMD) are measured by Anaesthesiologist and noted. In the operating room, laryngoscopy will be done by a qualified and experienced anaesthesiologist, who was blinded to the results of the preoperative airway assessment, and Glottic visualization will be assessed and noted according to modified Cormack Lehane grade. |