| CTRI Number |
CTRI/2017/05/008487 [Registered on: 04/05/2017] Trial Registered Prospectively |
| Last Modified On: |
09/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare, the effect of applying pressure at the end of the breathing tube on the function of lung, between laparoscopic and non laparoscopic surgeries |
|
Scientific Title of Study
|
To compare the effect of positive end expiratory pressure on dynamic pressure volume loop in laparoscopic and non laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Sri Ramachandra University
Porur
Chennai - 600016 |
|
|
Primary Sponsor
|
| Name |
Sree Kumar E J |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai 600088 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Sree Kumar E J |
Department of Anesthesiology, 6th floor,Sri Ramachandra University |
Porur Chennai 600116
Chennai
TAMIL NADU |
8056564566
sreekumardr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients coming for elective surgical procedures under general anesthesia, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEEP in laparoscopic surgery |
After insufflation of the abdomen, serial PEEP (positive end expiratory pressure) of 0, 4, 7 and 10 cm H2O is applied and the pressure volume loop is saved after 4 minutes |
| Comparator Agent |
PEEP in non laparoscopic surgery |
serial PEEP of 0, 4, 7 and 10 cm H2O is applied and the pressure volume loop is saved after 4 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
Thoracic surgeries
Respiratory diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in maximum curvature and compliance of pressure volume loop |
4 minutes after applying PEEP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2017 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an comparitive study to find out the optimal Positive end expiratory pressure (PEEP) during laparoscopic surgery using the change in maximum curvature and compliance of the pressure volume loop. After selecting the patients by the inclusion and exclusion criteria, they undergo standard anesthetic technique. Standard monitoring including the spirometry which is routinely performed is attached. After application of various PEEP ( 0, 4, 7 and 10 cmH2O) the spirometry loop is photographed and saved. The study is stopped if there is any hemodynamic disturbances. The study hypothesis is that optimum PEEP can be found by change in maximum curvature.
|