| CTRI Number |
CTRI/2025/07/090398 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate Cuff pressure in adults undergoing Open and Laparoscopic surgeries and associated postoperative complaints |
|
Scientific Title of Study
|
A Randomised study to compare the Endotracheal tube cuff pressure during laparoscopic and open surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shadab Mohammad gulhasan khan |
| Designation |
Resident Doctor Anesthesiology |
| Affiliation |
BJ Medical College, Ahmedabad |
| Address |
D-202, Gulshanefaiz, Ankleshwar, Bharuch,393001
Gujarat, India
F3,first floor, Department of Anaesthesia , Civil hospital, Asarwa Ahmedabad
Ahmadabad
GUJARAT
393001
India |
| Phone |
8200965119 |
| Fax |
|
| Email |
shadab105996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita R Engineer |
| Designation |
Proff and Head of Dept of Anaesthesiology |
| Affiliation |
BJ medical College, Ahmedabad |
| Address |
F3 Department of Anaesthesia 1st Floor Trauma Building Civil hospital campus Asarwa Ahmadabad Gujarat 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita R Engineer |
| Designation |
Proff and Head of Dept of Anaesthesiology |
| Affiliation |
BJ medical College, Ahmedabad |
| Address |
F3 Department of Anaesthesia 1st Floor Trauma Building Civil hospital campus Asarwa Ahmadabad Gujarat 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government of Gujarat Health and family welfare department,7th floor,New sachivalay, gandhinagar 382010 gujarat |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department,7th floor,New sachivalay, gandhinagar 382010 gujarat |
| Type of Sponsor |
Government medical college |
|
|
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 Shadab khan |
Major Surgery OT , Gynaec OT |
5th floor Trauma centre building,Civil hospital campus
Gynec- 1st floor ,1200 bed hospital
Ahmadabad
GUJARAT |
8200965119
shadab105996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee B.J. Medical College and civil hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal tube cuff pressure |
To compare changes in cuff pressure in patients undergoing open and Laparoscopic Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to consent for the study
2. Age :18 to 65 years( BMI- 18 to 35)
3. Either gender
4. American Society of Anesthesiologist (ASA) Classification I, II, III
5. Elective Surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult Intubation , history of Tracheostomy.
2. Patients with pre-existing uncompensated Lung and cardiac illness.
3. American society of anesthesiologist (ASA) Classification IV and V.
4. Pregnant patients.
5. Patient refusal to give consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes in ETT cuff pressure in laparoscopic and open abdominal surgeries. |
Every 15minutes intraperatively, followed by 3,6,9,12,18,24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To co rre late E TT c uff pressure c hange s in head up and head d ow n position.
2. To correlate ETT cuff pressure changes and POST, difficulty in Swallowing and
change of voice.
3.To Com pare changes in Intraoperative haem odynam ic variables (SBP,DBP,M AP,and
HR Intra-op )
|
3,6,9,12,18,24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/07/2025 |
| 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="0"
Months="7"
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
|
Endotracheal Tube is the preferred airway device for almost all complex general anaesthesia cases.The Endotracheal tube cuff is a device that protect the lung from aspiration of gastric contents, blood, secretions, and other fluid s & facilitating positive pressure ventilation.Normal cuff pressure should be between 20 -30 cm H2O, cuff pressure above 30 cm H2O obstructs the tracheal wall blood flow. Nowadays,Laparoscopic surgeries are gaining popularity because of a smaller incision,decreased pain, faster ambulation and short hospital stay.For laparoscopic surgeries general anaesthesia with cuffed Endotracheal tube intubation and controlled ventilation remains the safe technique of anaesthsia. However increase endotracheal tube cuff pressure resulting from pneumoperitoneum may raise the risk of cough, sorethroat, hoarseness and blood streaked expectoration.In addition, Factors such as position of patient head and neck, tredelenburg position, Duration of ETT placement, cuff volume ,use of nitrous oxide and degree of neuromuscular blockage affects ETT cuff pressure .
Very few studies on ETT cuff pressure changes in open abdominal surgery has been done.This study is planned to evaluate ETT cuff p ressure changes during laparoscopic and open abdominal surgeries,the correlation between pneumoperitoneum time, head up and head down position with changes in cuff pressure and POST.
|