| CTRI Number |
CTRI/2025/04/083881 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing lung pathophysiology in the preoperative and postoperative period among obese and overweight patients undering laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of perioperative atelectasis grading in elective laparoscopic surgeries between obese and overweight patients using a modified lung ultrasound score |
| Trial Acronym |
PALUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
indragandhi |
| Designation |
Assistant professor |
| Affiliation |
sri venkataeswra medical college and research center |
| Address |
no 21,2nd cross marial nagar,reddiarpalayam pudhucherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
8903259203 |
| Fax |
|
| Email |
indragandhi1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
indragandhi |
| Designation |
Assistant professor |
| Affiliation |
sri venkataeswra medical college and research center |
| Address |
no 21,2nd cross marial nagar,reddiarpalayam pudhucherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
8903259203 |
| Fax |
|
| Email |
indragandhi1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
indragandhi |
| Designation |
Assistant professor |
| Affiliation |
sri venkataeswra medical college and research center |
| Address |
no 21,2nd cross marial nagar,reddiarpalayam pudhucherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
8903259203 |
| Fax |
|
| Email |
indragandhi1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI VENKATESWARA MEDICAL COLLEGE AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
The Dean |
| Address |
sri venkateswara medical college and research institute ariyur,pondicherry |
| 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 |
| INDRAGANDHI |
OT-ANESTHESIA DEPARTMENT |
SRI VENKATESWARA MEDICAL COLLEGE AND RESEARCH CENTER ARIYUR PONDICHERRY
Pondicherry
PONDICHERRY |
8903259203
indragandhi1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI VENKATESWARA MEDICAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To calculate modified lung ultrasound score |
Group A- Overweight (BMI 25- 29.9 kg/m 2)
Group B- Obese (BMI 30- 34.9 kg/m 2 ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index 25-35kilogram per square metre
American society of anaesthesiologist class 1,2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Known lung pathology, diaphragmatic dysfunction,post thoracic surgery
difficult airway
obstructive sleep apnoea
liver and renal dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the grading of perioperative atelectasis using modified lung ultrasound score in different time intervals between the groups |
to compare the grading of perioperative atelectasis using modified lung ultrasound score in 4 different time intervals between the groups and within the groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the total modified lung ultrasound scores among the two groups and also to correlate the duration of surgery, length of ICU stay, requirement of postoperative oxygen supplementation, nebulization and incentive spirometry |
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
30/04/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [indragandhi1993@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The role of ultrasonography in pulmonary imaging has gained importance recently to identify atelectasis. Moreover, the Trendelenburg position used in laparoscopic gynaecologic or colon surgery causes the abdominal contents to push the diaphragm more cephalad, resulting in aggravated lung collapse and decreased functional residual capacity. Intraoperative atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury. Moreover, atelectasis can persist postoperatively and results in respiratory complications, such as hypoxemia, increased ICU stay, oxygen supplementation and infection which significantly impacts patient recovery. Hypothesis of this study is perioperative atelectasis grading more in obese patient than overweight patient for laparascopic surgery cases. This study aims to assess the grading of perioperative atelectasis in patients undergoing elective laparoscopic surgery under general anaesthesia using modified lung ultrasound score (LUS). |