| CTRI Number |
CTRI/2023/03/050607 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Observation study of endotracheal tube cuff pressure changes during laparoscopic surgery in head up and head down position. |
|
Scientific Title of Study
|
Observational analysis of endotracheal tube cuff pressure changes during laparoscopic surgeries in trendelenberg and reverse trendelenberg position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini |
| Designation |
professor |
| Affiliation |
rajarajeshwari medical medical college |
| Address |
rajarajeshwari medical college hospital
second floor operation theatre
Bangalore
KARNATAKA
560074
India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini |
| Designation |
professor |
| Affiliation |
rajarajeshwari medical medical college |
| Address |
rajarajeshwari medical college hospital
second floor operation theatre
Bangalore
KARNATAKA
560074
India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini |
| Designation |
professor |
| Affiliation |
rajarajeshwari medical medical college |
| Address |
rajarajeshwari medical college hospital
second floor operation theatre
Bangalore
KARNATAKA
560074
India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari medical college hospital |
|
|
Primary Sponsor
|
| Name |
Rajarajeshwari medical college hospital |
| Address |
Rajarajeshwari medical college hospital |
| 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 |
| DRASHWINI |
rajarajeshwari medical college hospital |
second floor opearation theatre
Bangalore
KARNATAKA |
08971265579
drashwinih@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| rajarajeshwari medical college and hospital ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
laparoscopic cholecystectomies in reverse trendelenberg position and laparoscopic hysterectomies in reverse trendelenberg position. |
|
| ExclusionCriteria |
| Details |
surgeries longer than 4hrs, laparoscopic surgeries in supine position. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in endotracheal tube cuff pressure |
before pneumoperitoneum, every 15 minutes after pneumoperotoneum, after desuflation and before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
17/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal tube cuff pressure should be kept within optimal range that ensures ventilation and prevents aspiration and postoperative sore throat. Recent studies have shown increase in cuff pressure with pneumoperitoneum and trendelenberg position adopted during laparoscopic surgeries. This study aims at identifying the cuff pressure changes with pneumoperitoneum and with changes in position during laparoscopic surgeries |