| CTRI Number |
CTRI/2024/04/066235 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe the lung changes in patients undergoing laparoscopic gall bladder removal and laparoscopic gynaecological surgeries under General Anaesthesia using lung ultrasonography score |
|
Scientific Title of Study
|
ASSESSMENT OF PERIOPERATIVE ATELECTASIS IN
LAPAROSCOPIC CHOLECYSTECTOMY AND LAPAROSCOPIC
GYNECOLOGICAL SURGERIES USING LUNG ULTRASOUND
SCORE |
| 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 Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Dr. B.R Ambedkar Medical College |
| Address |
Department of Anesthesiology, OT Complex,1st floor room no.6 Dr B R Ambedkar Medical College and Hospital, bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Dr. B.R Ambedkar Medical College |
| Address |
Department of Anesthesiology, OT Complex,1st floor, room no.6Dr B R Ambedkar Medical College and hospital Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva Shivaram |
| Designation |
Post Graduate Resident |
| Affiliation |
Dr. B.R Ambedkar Medical College |
| Address |
Department of Anesthesiology, OT Complex,1st floor, room no.6 Dr B R Ambedkar Medical College and hospital Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9731277443 |
| Fax |
|
| Email |
apoorva.shivram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ot complex, Dr B R Ambedkar Medical College and hospital , bangalore |
|
|
Primary Sponsor
|
| Name |
Apoorva Shivaram |
| Address |
OT Complex Dr B R Ambedkar Medical College Bangalore |
| 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 |
| DrApoorva Shivaram |
DR B R AMBEDKAR MEDICAL COLLGE AND HOSPITAL |
Department of Anesthesiology, OT Complex,1st floor.
Bangalore
KARNATAKA |
9731277443
apoorva.shivram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Laparoscopic Cholecystectomy |
Assessment of intraoperative lung collapse in Laparoscopic Cholecystectomy procedures using Ultrasonography using lung ultrasound score |
| Intervention |
Laparoscopic Gynecological procedures |
Assessment of intraoperative lung collapse in Laparoscopic Gynecological procedures using Ultrasonography using lung ultrasound score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for laparoscopic cholecystectomy and laparoscopic gynecological procedures.
2. Age >18 years
3. American Society of Anaesthesiologists Class 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic obstructive pulmonary disease
2. Diaphragmatic paralysis, previous thoracic surgeries, neuromuscular
diseases.
3. Cardiac Diseases.
4. BMI>35kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure intraoperative Lung ultrasound score in twelve lung quadrants. |
from preoperative period to 30 minutes post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess intraoperative hemodynamic parameters
To assess complications which include capnothorax, endobronchial
intubation & gas embolism. |
from preoperative period to 30 minutes post operatively |
|
|
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)
|
12/05/2024 |
| 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="4"
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 - NO
|
|
Brief Summary
|
Approximately 90% of surgical patients develop perioperative atelectasis by loss of aeration followed by positive pressure mechanical ventilation. Intra-abdominal pressure increases due to pneumoperitoneum during laparoscopic or robotic surgeries leading to an upward shift in the diaphragm and a decrease in lung compliance which induces lung collapse and a decrease in functional residual capacity (FRC). Aeration loss during pneumoperitoneum surgery in Trendelenburg position induces perioperative atelectasis, increased pulmonary vascular resistance(PVR) and possible development of postoperative pulmonary complications (PPCs) including pneumonia and acute lung injury. Effective management of emergencies such as atelectasis and pneumothorax , anaesthesiologists require quick and reliable diagnostic tools. Spirometry and radiography are known for their low accuracy and limitations. Ultrasound is a safe and easy to use point of care imaging (POCUS) that is becoming more widely used in modern anaesthesiology. Bedside lung ultrasound(LUS) has the advantages of accuracy, sensitivity, non-invasiveness, non- radiation and convenience .It has been a powerful approach for the diagnosis of atelectasis, pleural effusion and pneumothorax, and assessing aeration loss in patients exhibiting hypoxemia in anaesthetized patients perioperatively.In our study we will be performing lung ultrasound with patient in supine position. The lungs is divided into six quadrants with longitudinal (anterior, posterior axillary lines) and axial lines(nipple line). Each lung quadrant is numbered as one to six from caudal to cranial direction and divided into anterior (1,2), lateral(3,4),and posterior (5,6) axis by longitudinal line. The depths is adjusted in individual cases while finding two adjacent ribs to obtain the image of pleura which is called ‘bat sign’ and finding two adjacent B-lines with synchronized movement of the pleura. Scoring is done based on Modified Lung ultrasound with a minimum of 3 and maximum of 36. Each quadrant ranged from 0 to 3. Addition of all the quadrants will give us the respective results. Modified Lung ultrasound score: • 0- normal aeration. 0-2 B lines. • 1- small loss of aeration.> 3 B lines or multiple small subpleural consolidations separated by a normal pleural line quadrant • 2- moderate loss of aeration. Multiple coalescent B lines or multiple small subpleural consolidation separated by thickened or irregular pleural line. • 3- severe loss of aeration. Consolidation or small subpleural consolidation > 1 x 2 cm in diameter. We consider pulmonary atelectasis to be significant when LUS is >2 in any region. |