CTRI Number |
CTRI/2025/05/087214 [Registered on: 20/05/2025] Trial Registered Prospectively |
Last Modified On: |
20/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
to compare changes of wind pipe opening in patients above 65 years,in their back elevated to 20 degrees and lying flat positions using camera. |
Scientific Title of Study
|
To compare the video laryngoscope Percentage of glottic opening view in supine and back elevated to 20 degree in patients above 65 years. 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 |
T R SUDHARSAN |
Designation |
POST GRADUATE |
Affiliation |
CHRISTIAN MEDICAL COLLEGE VELLORE |
Address |
Department of Anesthesia
Christian Medical college
Vellore Department of Anesthesia
Christian Medical College
Vellore Vellore TAMIL NADU 632004 India |
Phone |
9659837577 |
Fax |
|
Email |
imsusa04@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Tony Thomson Chandy |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Department of Anesthesia
Christian Medical College
Vellore Department of Anesthesia
Christian Medical College
Vellore Vellore TAMIL NADU 632004 India |
Phone |
04162282105 |
Fax |
|
Email |
tonythomson@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Sudharsan |
Designation |
Post graduate |
Affiliation |
CHRISTIAN MEDICAL COLLEGE |
Address |
Department of Anesthesia
Christian Medical College
Vellore
Department of Anesthesia
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
Phone |
04162282105 |
Fax |
|
Email |
imsusa04@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Christian Medical College Fluid Research Grant |
Address |
Christian Medical College
Thottapalayam
Vellore 632004 |
Type of Sponsor |
Research institution and hospital |
|
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 |
T R SUDHARSAN |
Operating Rooms |
Department of Anesthesia
Christian Medical College
Vellore 632004 Vellore TAMIL NADU |
9659837577
imsusa04@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
The Institutional Review Board Ethics and Research Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C178||Malignant neoplasm of overlappingsites of small intestine, (2) ICD-10 Condition: K460||Unspecified abdominal hernia withobstruction, without gangrene, (3) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, (4) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
65.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Age more than 65 years
Both Male and Female patients |
|
ExclusionCriteria |
Details |
BMI more than 35
ASA 3 and 4
Cardiac surgery patients
Immobile cervical spine
Intra oral tumors
IID less than 2mm. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine the difference in laryngoscopy view between supine and 20 degree back elevated position patients above 65 years |
baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the time for successful intubation in back up position |
baseline |
To assess the attempts needed for successful endotracheal intubation |
baseline |
To measure the decrease in oxygen saturation during intubation |
baseline |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
02/06/2025 |
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="2" Days="30" |
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
|
Physiological and airway anatomical changes in the elderly challenges rapid securing the airway. Limited oxygen reserve, systemic and end organ comorbidities leads to increased morbidity and mortality during laryngoscopy and intubation in the elderly. Optimisation of the head and neck position improves laryngoscopic view and endotracheal intubation. The sniffing position is forward flexion of cervical spine and head extension at the atlantooccipital joint aligns oropharyngeal and laryngeal axes. In the geriatric population, the glottis view is difficult due to restrictive changes at atlantoaxial joint and cervical vertebrae mobility along with muscle tone and altered physiologic changes. Recent evidence suggests that positioning the patient prior to intubation with backup elevation compared to the classical sniffing position improves laryngeal inlet visualization. Therefore decreasing time to intubation of the trachea thus preventing and minimizing the effects of hypoxia on the geriatric cerebral cognitive function along with prevention of myocardial ischemia. Similar studies has not explored the effectiveness of the backup position in the elderly population. This study proposes to compare the glottic opening views between supine and back up position in the same patient.
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