| CTRI Number |
CTRI/2024/05/068002 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on two methods of windpipe fixation |
|
Scientific Title of Study
|
Comparative study of two different tube fixation methods for optimal positioning of Endotracheal Tube |
| 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 Remya Gopinath |
| Designation |
PG Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amrita Institute of Medical Sciences, Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
04842851234 |
| Fax |
|
| Email |
remyagopinathaswin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Varghese |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amrita Institute of Medical Sciences, Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
04842851234 |
| Fax |
|
| Email |
rekhavarghese@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Varghese |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amrita Institute of Medical Sciences, Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
04842851234 |
| Fax |
|
| Email |
rekhavarghese@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Amrita Institute of Medical Sciences, AIMS Ponekkara P.O, Ernakulam, PIN-682041 |
|
|
Primary Sponsor
|
| Name |
AMRITA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology
Amrita Institute Of Medical Sciences
Kochi
|
| 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 |
| Dr Remya Gopinath |
Amrita Institute of Medical Sciences |
Department of Anaesthesiology, AIMS Ponekkara P.O, Ernakulam, PIN-682041
Ernakulam
KERALA |
9446409881
remyagopinathaswin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal Tube cuff sitting beyond one centimeter from cricoid cartilage |
Safe method of tube fixation is Endotracheal Tube cuff sitting beyond one centimeter from cricoid cartilage |
| Intervention |
Endotracheal Tube Fixation by black mark on the Endotracheal Tube just passing vocal cords and Endotracheal Tube Fixation by Suprasternal palpation of the Endotracheal Tube cuff |
These are the Two methods of Endotracheal Tube Fixation and the study compares the two methods for identifying the safest one |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ALL ASA I & II PATIENTS COMING FOR ELECTIVE SURGERY |
|
| ExclusionCriteria |
| Details |
Front of neck anomalies which makes the scanning difficult & in patients with previous tracheal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Two groups are compared to determine which group hasmore number of cuffs sitting beyond 1cm from cricoid cartilage |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fibreoptic measurement of tube tip to carina distance2-7 cm |
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
10/06/2024 |
| 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="2"
Months="6"
Days="10" |
|
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
|
A study on optimal positioning of endotracheal tube by two tube fixation methods. Study aim to determine which method of depth assessment for fixation results in better safety profile. |