| CTRI Number |
CTRI/2025/05/086661 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Oxygen Levels on Lung function During Laparoscopic Surgery |
|
Scientific Title of Study
|
Determining the effect of fraction of inspired
oxygen during alveolar recruitment on absorption atelectasis in laproscopic surgery
using lung ultrasound score: A one year randomised clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejesh S |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of anaesthesiology, KLES Dr Prabhakar Kore hospital and medical research center. Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7795348048 |
| Fax |
|
| Email |
tejeshseenappa@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitanya A Kamat |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of anaesthesiology, KLES Dr Prabhakar Kore hospital and medical research center. Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8150038305 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejesh S |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of anaesthesiology, KLES Dr Prabhakar Kore hospital and medical research center. Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
77953484048 |
| Fax |
|
| Email |
tejeshseenappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore hospital and medical research center. Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka, India 590010 |
|
|
Primary Sponsor
|
| Name |
Tejesh S |
| Address |
Department of anaesthesiology, KLES Dr Prabhakar Kore hospital and medical research center. Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Tejesh |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
7795348048
tejeshseenappa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee, Jawaharlal medical college, Nehru nagar, Belagavi |
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, (2) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fraction of inspired oxygen 100% |
After setting the FIO2 (100%) according to the
assignment, continuous positive airway pressure will be applied from 20 cmH2O in 5-
cmH2O stepwise increments, up to 35 cmH2O |
| Intervention |
fraction of inspired oxygen 40% |
After setting the FIO2 (40%) according to the
assignment, continuous positive airway pressure will be applied from 20 cmH2O in 5-
cmH2O stepwise increments, up to 35 cmH2O |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient with healthy, no respiratory symptoms, no pre-existing lung pathologies (negative CXR)
2) Age between 18-60 years
3) BMI more than 35 kg/m2
4) ASA I & II
5) Elective laproscopic surgeries in trendelenberg position.
|
|
| ExclusionCriteria |
| Details |
ASA grade III & IV
Patient with pulmonary, cardiac and neuromuscular diseases.
Corresponding thorasic surgical history and respiratory tract
infection were excluded.
Those undergoing conversion from laproscopic to open surgery.
Those experiencing critical postoperative complication such as severe
subcutaneous emphysema and peunmothorax.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of atelectasis in patients undergoing laproscopic surgery under general anaesthesia receiving lung recruitement maneuver with two different Fio2 concentration of 0.4 and 1.0 . |
To compare the incidence of atelectasis in patients undergoing laproscopic surgery under general anaesthesia receiving lung recruitement maneuver with two different Fio2 concentration of 0.4 and 1.0 . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative pulmonary complications. |
preoperatively and postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| 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="0"
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
|
its a novel study comparing the effect of lung recruitment manouvres with two different fractions of inspired oxygen concentrations on absorption atelectasis and prevention of post operative pulmonary complications in patients undergoing laparoscopic lower abdominal surgeries in trendelenburg position under general anaesthesia. lung ultrasound scoring is used to assess the said post op complications. |