| CTRI Number |
CTRI/2025/09/094412 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Types Of Suction Tubes Used To Clear The Secretions of Airway During Endotracheal Tube Removal A Study With Randomly Selected Patients Undergoing All Elective Surgeries Requiring Endotracheal Tube Insertion |
|
Scientific Title of Study
|
Comparison Of Yankauer Suction Catheter Versus Flexible Suction Catheter For Airway Suctioning During Extubation . A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Posa Sai Nayana |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9985103218 |
| Fax |
|
| Email |
nayana12396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Prasad T |
| Designation |
Professor in Anaesthesiology |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Posa Sai Nayana |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9985103218 |
| Fax |
|
| Email |
nayana12396@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Posa Sai Nayana |
| Address |
SSSMCRI Womens hostel
Shri Sathya Sai Medical College and Research Institute
2nd floor OT complex room no 1 Ammapettai Kancheepuram Tamil Nadu India |
| 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 |
| Posa Sai Nayana |
Shri Sathya Sai Medical College and Research Institute |
Shri Sathya Sai Medical College and Research Institute 2nd floor OT complex room no 1 Department of Anaesthesiology
Ammapettai Kancheepuram Tamil Nadu India 603108
Kancheepuram
TAMIL NADU |
9985103218
nayana12396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60years
Elective surgeries requiring general anaesthesia with endotracheal intubation
ASA physical status 1 to 4 |
|
| ExclusionCriteria |
| Details |
Pre existing pulmonary pathology eg COPD Asthama
Difficult airway or anticipated difficult extubation
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effective in help deciding the suction catheters for safer extubation reduce airway related complications |
Baseline at 20minutes at 40minutes at 2hours at 6hours at 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/09/2025 |
| 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="6"
Days="0" |
|
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
|
This is a single-blinded randomized controlled trial comparing the effectiveness of the Yankauer suction catheter and the flexible suction catheter for airway suctioning during extubation in adult patients undergoing elective surgeries under general anaesthesia.
The study will be conducted at a tertiary care centre between August 2025 and January 2027, with a sample size of 66 patients 33 in each group Primary outcome is clinician satisfaction with ease of use and effectiveness of secretion clearance. Secondary outcomes include post-extubation complications injuries laryngospasm cough aspiration and the time and frequency of suctioning.
Findings from this study may help determine the safer and more effective suction catheter to use during extubation, improving patient safety and minimizing airway-related complications |