| CTRI Number |
CTRI/2025/06/088017 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of laparoscopic surgeries on diaphragm function using ultrasonography |
|
Scientific Title of Study
|
A prospective observational study to compare pre and post operative diaphragm excursion on ultrasonography in laparoscopic abdominopelvic surgery patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arundhati Sharma |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8291446494 |
| Fax |
|
| Email |
arks8401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarojini Bobde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8291446494 |
| Fax |
|
| Email |
sarojini.bobde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arundhati Sharma |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8291446494 |
| Fax |
|
| Email |
arks8401@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Arundhati Sharma |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Dhankawadi
Pune
India
411043 |
| Type of Sponsor |
Other [Other (self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSarojini Bobde |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Dhankawadi
Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arundhati Sharma |
Bharati Hospital and Research Centre |
Major operation theatre
3rd floor
Bharati Hospital and Research Centre
Pune-satara road
pin code 411043
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8291446494
arks8401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II patients posted for laparoscopic abdominopelvic surgeries under GA of duration 2 hours and more |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in study, patients with pre existing diaphragm dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of laparoscopic abdominal surgeries on diaphragm excursion |
diaphragm excursion measurement at 0 hours(pre induction),1 and 1.5 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
association of position of patient and type,duration of procedure with extent of variation in diaphragm excursion
post operative excursion and SpO2 with O2 requirement
|
intra-operative and post operative upto 1 and 2.5 hours
post operatively upto 6 hours
|
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
15/06/2025 |
| 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="5"
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 prospective observational study will be conducted in ASA I and II patients posted for laparocopic abdominopelvic surgeries under general anaesthesia Primary aim is to compare the pre and post-operative diaphragm excursion on ultrasonography in laparoscopic surgery
Secondary objectives include association of type, duration of patient with position of patient with extent of variation in diaphragm excursion and co relation of post-operative diaphragm excursion with post operative SpO2 and oxygen requirement |