| CTRI Number |
CTRI/2023/09/057551 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of loss of lung aeration during laparoscopic gynecological procedures using lung ultrasound |
|
Scientific Title of Study
|
Study of bilateral six quadrant lung ultrasound score in patients undergoing laparoscopic gynecological surgery |
| 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 Rachana Pole Sathyendranath |
| Designation |
Post graduate |
| Affiliation |
DR. B R Ambedkar medical college and hospital |
| Address |
Department Of Anaesthesiology, Dr. B R Ambedkar medical college and hospital, K G halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9113623543 |
| Fax |
|
| Email |
rachanapole95.rp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsoor S S |
| Designation |
Head of the department and Proffesor |
| Affiliation |
Dr. B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesia,
DR. B R Ambedkar medical college and hospital, K G Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachana Pole Sathyendranath |
| Designation |
Post Graduate |
| Affiliation |
Dr. B R Ambedkar medical college and hospital |
| Address |
Department of anaesthesia, DR. B R Ambedkar medical college and hospital, K G Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9113623543 |
| Fax |
|
| Email |
rachanapole95.rp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital, k g halli, bangalore 560045 |
|
|
Primary Sponsor
|
| Name |
Dr Rachana Pole Sathyendranath |
| Address |
Department of Anesthesiology, DR. B R Ambedkar medical college and hospital, Bengaluru
|
| 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 Rachana Pole Sathyendranath |
Dr B R Ambedkar medical college and hospital |
Department of anaesthesiology,1st floor, OT complex
Bangalore
KARNATAKA |
9113623543
rachanapole95.rp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.patients posted for elective laparoscopic gynecological surgery
2.patients with BMI <35kg/m2
3.American society of Anaesthesiologists class
I and II
|
|
| ExclusionCriteria |
| Details |
1.patients with known pulmonary pathology
2.pregnant women
3.patients with known cardiac and neuromuscular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure perioperative lung ultrasound score in twelve lung quadrants |
15 minutes prior to induction of general anesthesia to 15 minutes post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess intraoperative complications which includes capnothorax endobronchial intubation & gas embolism |
15 minutes prior to induction of general anesthesia to 15 minutes post extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/09/2023 |
| 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="6"
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
|
Atelectasis is the most common cause for development of postoperative pulmonary complications. the incidence of atelectasis is approximately 90% in all patients receiving general anesthesia. laparoscopic surgeries are gaining more popularity in the present days due to its advantages which include minimal incisions, clear surgical views and reduced postoperative stay, however pneumoperitoneum and trendelenburg position leads to hypoxemia which increases the risk of post operative pulmonary complications. therefore preventing perioperative atelectasis becomes challenging. incorporating lung ultrasound in modern anesthesia practise helps clinicians to manage critical situation swiftly in real time and prevent any further life threatening complications. in our study we will be performing lung ultrasound by placing the probe in bilateral six quadrants, each hemithorax divided into upper and lower zones which is further divided into anterior ,lateral and posterior zones by anterior and posterior axillary lines. lung ultrasound score is a semiquantitative ecographic score of lung aeration. LUS will be calculated by adding the scores of twelve individual quadrants ranging from 0 to 36. higher score suggest chronic atelectasis. we consider pulmonary atelectasis to be significant when LUS A> 2 in any region. |