| CTRI Number |
CTRI/2025/10/095690 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Using Shoulder and Neck Measurements to Predict Breathing Tube Placement Difficulty in Patients undergoing surgery. |
|
Scientific Title of Study
|
A prospective observational study of the performance of the acromioaxillosuprasternal notch index in predicting difficult visualization of the larynx |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathish kumar M |
| Designation |
MD Anesthesiology Post graduate |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103
Chennai TAMIL NADU 603103 India |
| Phone |
9840380716 |
| Fax |
|
| Email |
sathishkumar2march95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Ashok kulasekar |
| Designation |
Head of the department, Anesthesiology. |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103
Chennai TAMIL NADU 603103 India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Sathish kumar M |
| Designation |
MD Anesthesiology Post graduate |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103
Chennai TAMIL NADU 603103 India |
| Phone |
9840380716 |
| Fax |
|
| Email |
sathishkumar2march95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, india, pincode-603103. |
|
|
Primary Sponsor
|
| Name |
Sathish kumar M |
| Address |
Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103 |
| Type of Sponsor |
Other [This study is self-sponsored, with myself as the primary sponsor.] |
|
|
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 Sathish kumar M |
Chettinad hospital and research institute |
B block, 2nd floor, ICU-3, department of anesthesiology, chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103 Chennai TAMIL NADU |
9840380716
sathishkumar2march95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee for student research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
ASA grade -1,2
Patients undergoing surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient who denies consent
Patient with prominent features of the difficult airway with facial abnormalities
Morbid obesity BMI more than 35kg/sq.m
Restricted mouth opening, edentulous
Cervical spine anomalies
Uncooperative and pregnant patients
Patients with anatomical deformity of head, neck and thorax |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the incidence of difficult laryngoscopy(Cormack-lehane grade III-IV) measured at the time of laryngoscopy immediately after induction of anesthesia |
The outcome of difficult visualization of the larynx will be assessed at the time of laryngoscopy during induction of anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="85" Sample Size from India="85"
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)
|
01/11/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Inclusion criteria Age: 18-60 years , ASA grade -1,2 , Patients undergoing surgery under general anesthesia. Exclusion criteria Patients who denies consent, Patients with prominent features of the difficult airway with facial abnormalities, Morbid obesity body mass index BMI more than 35 kg/sq.m , Restricted mouth opening, edentulous, Cervical spine anomalies, Uncooperative and pregnant patients. Patients with anatomical deformity of head, neck, thorax. After obtaining approval from Ethics committee Informed and written consent will be obtained from all patients PREOPERATIVE ASSESSMENT including Detailed history and physical examination, baseline data like heart rate, blood pressure and basic investigations will be collected. Modified mallampatti grading (1,2,3,4), Mouth opening (more or less than 3 finger breath) ,Thyromental distance (more or less than 6.5 cm) , sternomental distance (more or less than 12.5cm) , Hyomental distance (more or less than 4.5 cm), inter incisor distance (more than or less than 4cm ), body mass index will be noted .An Intravenous access with 18G IV cannula will be secured for all patients. Premedication such as Tablet Ranitidine 150mg and Tablet Alprazolam 0.5mg given a night before surgery and 6 am on the day of surgery ACROMIO AXILLO SUPRASTERNAL NOTCH INDEX was measured with the patients lying in supine position and their upper limbs resting by the sides of the body Using a ruler a vertical line was drawn from top of the acromion process to the superior border of the axilla at the pectoralis muscle –line A The second line was drawn perpendicular to line A from the suprasternal notch – line B. The portion of line A that lay above the point at which line B intersected line A was termed as -line C .AASI was calculated by dividing the length of line C by that of line A ( AASI =C/A) . An AASI value of 0.49 or less has been identified as a predictor of difficult laryngoscopy (intubation) |