| CTRI Number |
CTRI/2024/04/066160 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the movement of diaphragm using ultrasonography to ensure safe respiration after anaesthesia and surgery |
|
Scientific Title of Study
|
EVALUATION OF DIAPHRAGMATIC EXCURSION CHANGES AFTER MAJOR LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHESIA
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHARANYA NARAYAN |
| 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-560045
Department Of Anaesthesiology, Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045
Bangalore
KARNATAKA
45
India |
| Phone |
9148403123 |
| Fax |
|
| Email |
narayansharanya.95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARSOOR S S |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| 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-560045
Department Of Anaesthesiology, Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHARANYA NARAYAN |
| 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-560045
Department Of Anaesthesiology, Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9148403123 |
| Fax |
|
| Email |
narayansharanya.95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045, India |
|
|
Primary Sponsor
|
| Name |
DR SHARANYA NARAYAN |
| Address |
Department Of Anaesthesiology, Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045 |
| 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 |
| DR SHARANYA NARAYAN |
OT Complex |
Department Of Anaesthesiology, Dr. B R Ambedkar Medical College And Hospital, K G Halli, Bengaluru-560045
Bangalore
KARNATAKA |
9148403123
narayansharanya.95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, Dr B R Ambedkar Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients posted for elective laparoscopic surgeries under general anaesthesia.
Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) I and II
|
|
| ExclusionCriteria |
| Details |
Patients with known neuromuscular disorders
Patients with diaphragmatic dysfunction
Patients with chronic respiratory illnesses
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare diaphragmatic excursions before and after major laparoscopic surgeries
|
From preop to shifting patient to recovery room post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To ensure adequate reversal from neuromuscular blockade
|
From extubation to shifting patient to recovery room |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
09/05/2024 |
| 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="1"
Months="6"
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
|
Ultrasound
has
emerged as a promising tool for evaluating diaphragmatic excursions
due
to its non-invasive nature and high reproducibility. The
study is being done to emphasize the feasibility and highlight clinical
relevance of assessment of diaphragmatic function in ensuring complete
reversal of neuromuscular blockade along with other clinical signs and neuromuscular monitoring |