| CTRI Number |
CTRI/2025/06/089512 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Clinical |
| Study Design |
Other |
|
Public Title of Study
|
Comparing changes in diaphragm function after robotic surgery and open surgery done under general anaesthesia |
|
Scientific Title of Study
|
Assessment of Diaphragmatic Function in Robotic Surgery vs Open Abdominal Surgery Under General Anaesthesia - A Prospective Observational 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 |
Dr Aishwarya R Katti |
| Designation |
Junior resident |
| Affiliation |
St. Johns Medical College Hospital, Bangalore |
| Address |
Department of Anaesthesiology
St Johns Medical College Hospital Sarjapura Main Road John Nagar Koramangala Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
919731592877 |
| Fax |
|
| Email |
aishukatti20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Bhimasen Joshi |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College Hospital, Bangalore |
| Address |
Department of Anaesthesiology
St Johns Medical College Hospital Sarjapura Main Road John Nagar Koramangala Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9901405136 |
| Fax |
|
| Email |
drshilpa.josh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Bhimasen Joshi |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College Hospital, Bangalore |
| Address |
Department of Anaesthesiology
St Johns Medical College Hospital Sarjapura Main Road John Nagar Koramangala Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9901405136 |
| Fax |
|
| Email |
drshilpa.josh@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital, Sarjapura Road, Koramangala, Bangalore-560034 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
St Johns Medical College Hospital Sarjapura Road Koramangala Bangalore 560034 |
| 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 Aishwarya R Katti |
St Johns Medical College Hospital |
Room No 3 2nd floor Operation Theatre complex St Johns Medical College Hospital Sarjapura Road Koramangala Bangalore 560034
Bangalore
KARNATAKA |
9731592877
aishukatti20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St Johns Medical College 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 |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2 patients between 18-60 years of age |
|
| ExclusionCriteria |
| Details |
Pregnant women
Preexisting lung and diaphragmatic dysfunction
Neuromuscular disease
Previous thoracic/abdominal surgery
Thoracic deformity
Poor imaging window
Patients with ascites, hepatic/renal disease coming for high risk surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess diaphragmatic function in patients undergoing robotic surgeries vs open abdominal surgeries |
Ultrasonography will be carried out prior to surgery (baseline), After completion of surgery at extubation and once subject is shifted to Post Anaesthesia Care Unit. All three assessments will be carried out the same day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the impact of age, gender, BMI, Respiratory parameters like Positive end expiratory pressure, peak airway pressures, lung compliance & surgery related parameters like pain, duration of pneumoperitoneum, duration of surgery, patient position on diaphragmatic function. |
All parameters will be assessed preoperatively (baseline)and at 5 minute time intervals after intubation, at creation of pneumoperitoneum, every 30 minutes thereafter & in the PACU. All recordings will be noted on the same day of surgery. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
29/08/2025 |
| 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="2"
Months="0"
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
|
The diaphragm is the main muscle of respiration. Diaphragmatic dysfunction can be mild
(weakness) or severe (with diaphragmatic paralysis). In the perioperative setting multiple factors
affect the diaphragmatic function such as surgical procedure, mechanical ventilation and post
operative pain. Unrecognized diaphragmatic dysfunction can result in several complications for
the patient including prolonged recovery time and postoperative pulmonary complications.
Over the years several methods of assessing diaphragmatic function have been used.
Ultrasonography of the diaphragm has turned out to be one of the most reliable methods for
bedside assessment of diaphragmatic dysfunction showing a sensitivity of 93% and specificity of
100% in neuromuscular disease. (1)
Over the years surgeries are evolving to become more and more minimally invasive to increase
patient comfort in the postoperative period and faster recovery. The evolution of robotic surgery
comes with a challenge as it is associated with unphysiological conditions from the
pneumoperitoneum created for the surgery. It results in a cephalad displacement of the
diaphragm and mechanical compression of the lungs. This can be further worsened depending on
the position of the patient during surgery as seen with trendelenburg position.
Perioperative use of diaphragmatic US is limited due to patient position factors and has not been
explored much. Through this study we aim to gain some insights on diaphragmatic dysfunction
occurring in surgeries involving creation of pneumoperitoneum as compared to open surgeries. |