| CTRI Number |
CTRI/2025/08/093110 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods for inflating breathing tube cuff in patients having laparoscopic gallbladder surgery under general anaesthesia. |
|
Scientific Title of Study
|
A comparative study of endotracheal tube cuff pressure between two techniques, using Pressure-Volume loop (PV-L) and Minimal occlusive volume (MOV) in patients undergoing laparascopic cholecystectomy under general anaesthesia, a prospective randomised controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himason Rai |
| Designation |
Post Graduate Trainee |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences, |
| Address |
Room no 1,PG classroom, Dept of Anaesthesiology, Main OT complex,level6, Central Referral Hospital,Sikkim Manipal Institute of Medical Sciences,5th Mile,Tadong, Gangtok,East Sikkim
5th Mile,Tadong,Gangtok,Sikkim.
East
SIKKIM
737102
India |
| Phone |
8927301883 |
| Fax |
|
| Email |
himasonrai1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Rai |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Consultants Room, level 6, OT complex,Dept of Anaesthesia, Central referral hospital, SMIMS Tadong, Gangtok, East Sikkim.
5th Mile,Tadong,Gangtok,Sikkim.
East
SIKKIM
737102
India |
| Phone |
9800046524 |
| Fax |
|
| Email |
Arati_401@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arati Rai |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Consultants Room, level 6, OT complex,Dept of Anaesthesia, Central referral hospital, SMIMS Tadong, Gangtok, East Sikkim.
5th Mile,Tadong,Gangtok,Sikkim.
East
SIKKIM
737102
India |
| Phone |
9800046524 |
| Fax |
|
| Email |
Arati_401@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No external funding, Supported by SMIMS, Central Referral Hospital,Department of Anaesthesia, for equipment and materials. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Himason Rai |
Central Referral Hospital |
Department of Anaesthesia, OT complex, level 6,Sikkim Manipal Institute of Medical Sciences,5th Mile,Tadong.
East
SIKKIM |
8927301883
himasonrai1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Minimal Occlusive Volume (MOV) technique for endotracheal tube cuff inflation |
After tracheal intubation, cuff inflation is guided by auscultation at the suprasternal notch to identify the minimal volume that prevents an audible leak during positive pressure ventilation. Final cuff pressure measured with the same calibrated cuff manometer. Measurements taken post-intubation, after pneumoperitoneum, every 15 min, and at the end of surgery.
|
| Intervention |
Pressure–Volume Loop (PV-L) guided endotracheal tube cuff inflation. |
After tracheal intubation, cuff inflation is guided using the pressure–volume loop displayed on the anaesthesia workstation to determine the minimal volume required to prevent air leak. Final cuff pressure measured with a calibrated cuff manometer. Measurements taken post-intubation, after pneumoperitoneum, every 15 min, and at the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I and II, both genders undergoing Laparascopic Cholecystectomy under general anaesthesia.
2.Age between 18 years and 60 years.
3.BMI less than 30kg |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent to the study,
2. Patients with anticipated difficult intubation,
3. Emergency intubations,
4. Known anatomical laryngotracheal abnormalities,
5. Patients with high risk of pulmonary aspiration, pre op sore throat & Upper respiratory infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The PV loop technique would be more accurate than MOV technique in acheiving the desired ETTc pressure in patients undergoing laparascopic cholecystectomy under general anaesthesia. |
The ETT cuff pressure will be measure post intubation and pre extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the endotracheal cuff volume with the two techniques
2.To compare the incidence of sore throat, cough & hoarseness of voice. |
Patients will be assesed at 2 hours, 6 hours & 24 hours post extubation. |
|
|
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)
|
25/08/2025 |
| 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 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 comparative study of endotracheal tube cuff pressure between two techniques, using Pressure-Volume loop (PV-L) and Minimal occlusive volume (MOV) in patients undergoing laparascopic cholecystectomy under general anaesthesia, a prospective randomised controlled study.
|