| CTRI Number |
CTRI/2025/08/092245 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of application of ultrasound guided and sustained inflation of lungs in Trendelenburg position in cases of robotic surgery |
|
Scientific Title of Study
|
Comparison of the effect of ultrasound guided and conventional lung recruitment manoeuvres in trendelenburg robotic 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 |
Shrishti Choudhary |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
7297802077 |
| Fax |
|
| Email |
shrishtichoudhary98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Banwait |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Banwait |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government 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 |
| Shrishti Choudhary |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari nagar
New delhi-110029
South
DELHI |
7297802077
shrishtichoudhary98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
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 |
| Intervention |
Lung Recruitment Manoeuvres |
Ultrasound guided lung recruitment manoeuvres and sustained inflation lung recruitment manoeuvres will be performed 5 minutes after induction and 5 minutes before extubation in patients undergoing trendelenburg robotic surgery.The efficacy of these will be measured and compared using lung ultrasound score. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years belonging to American society of anaesthesiology Physical status I and II undergoing trendelenburg robotic surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. body mass index greater than 35 KG per metre square
2. Any obstructive or restrictive pulmonary disease
3. Previous history of thoracic surgery, pneumothorax, bullae preexisting lung or cardiac disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in lung ultrasound scores after ultrasound guided lung recruitment manoeuvres and conventional lung recruitment manoeuvres in patients undergoing trendelenburg robotic surgery |
To assess the changes in lung, ultrasound scores after ultrasound guided lung recruitment manoeuvres and conventional lung recruitment manoeuvres in patients undergoing trendelenburg robotic surgery 5 minutes after induction of general anaesthesia and 5 minutes before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the lung ultrasound score at the time of discharge of the patient from recovery room.
2. To assess intra operative changes in oxygenation using intra operative oxygen saturation and arterial blood gas analysis. |
1. Baseline
2. Five minutes after induction of general anaesthesia.
3. Five minutes before extubation in patients
4. At the time of observation in recovery room. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="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
|
This study is a prospective, randomised, interventional, and comparative study to compare the effect of ultrasound guided and conventional lung recruitment manoeuvres in patients undergoingTrendelenburg robotic surgery, with the hypothesis that ultrasound guided recruitment manoeuvres have better efficacy as compared to the conventional lung recruitment manoeuvres. A baseline lung ultrasound score will be calculated before the induction of anaesthesia. In both the groups lung ultrasound examination will be done at two predefined time points ,five minutes after the induction of anesthesia and five minutes before extubation. After lung ultrasound examination, recruitment manoeuvres will be performed. In one group recruitment manoeuvres will be performed under direct real time guidance of ultrasound where in manual inflation will be applied till no collapse area is visible on the ultrasound. The maximum airway pressure will be adjusted 40 cm H2O. In the sustained inflation group recruitment manoeuvre will be performed by manual inflation with pressure of 30 cm for 10 seconds. Lung ultrasound score will be calculated 30 minutes after extubation when the patient is in recovery room. Patient will be observed in postop ward for one hour. |