| CTRI Number |
CTRI/2023/01/048832 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes of breathing tube position in Laparoscopic procedures |
|
Scientific Title of Study
|
Impact of intra abdominal pressure and reverse trendelenburg position on endotracheal tube migration during laproscopic procedures - An Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annu Theagrajan |
| Designation |
Assistant Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College & Hospital |
| Address |
Department of Anaesthesiology,
3rd Floor Hospital Building,
#7, Works Road, New colony,
Chromepet.
Chennai
Chennai
TAMIL NADU
600044.
India |
| Phone |
9901834935 |
| Fax |
|
| Email |
drannuprahlad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Annu Theagrajan |
| Designation |
Assistant Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College & Hospital |
| Address |
Department of Anaesthesiology,
3rd Floor Hospital Building,
#7, Works Road, New colony,
Chromepet.
Chennai
Chennai
TAMIL NADU
600044.
India |
| Phone |
9901834935 |
| Fax |
|
| Email |
drannuprahlad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghuraman M S |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College & Hospital |
| Address |
Department of Anaesthesiology,
3rd Floor Hospital Building,
#7, Works Road, New colony,
Chromepet.
Chennai
Chennai
TAMIL NADU
600044.
India |
| Phone |
6379141854 |
| Fax |
|
| Email |
drraghuram70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College & Hospital |
| Address |
#7, Works Road, New colony,
Chromepet.
Chennai – 600044. INDIA.
|
| Type of Sponsor |
Private 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 Annu Theagrajan |
Sree Balaji Medical College & Hospital |
4th Floor OT Complex,
Department of Anaesthesiology,
#7, Works Road, New colony,
Chromepet.
Chennai – 600044. INDIA.
Chennai
TAMIL NADU |
9901834835
drannuprahlad@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing laproscopic surgery in reverse Trendelenburg position at Sree Balaji Medical College and Hospital. |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Hyperactive airway
Patients in whom the procedure has been converted to open surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in depth of endotracheal tube after pneumoperitoneum and reverse Trendelenburg positioning |
The primary outcome will be assessed during the following events
1.Supine position after intubation
2.15 degree Trendelenburg positioning
3. after pneumoperitoneum creation
4. 25 mins after pneumoperitoneum
5. After deflation in reverse Trendelenberg position
6. After deflation in supine position
6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/01/2023 |
| Date of Study Completion (India) |
11/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/01/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intrabdominal pressure ( pneumoperitoneum) created during laproscopic procedures can cause cephalad movement of the diaphragm and subsequently can cause migration of endotracheal tube tip towards carina thereby increasing the risk of endobronchial migration. similarly, the patient position can also cause endotracheal tube migration within the tracheobronchial tree. Previous studies have assessed in other positions. Hence we wish to assess these changes in Reverse Trendelenburg. |