| CTRI Number |
CTRI/2025/07/091471 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound as a tool to detect pulmonary changes after major abdominal onco surgery |
|
Scientific Title of Study
|
Ultrasound as a tool to detect pulmonary changes after major abdominal onco surgery a prospective observational 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 Arghya Mukherjee |
| Designation |
Senior Consultant and Head Department Of Onco Anaesthesia And Peri Operative Care |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Room No 2
Department of Onco Anaesthesia
Oncology Building
Medica Superspecialty Hospital
127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal 700099
Kolkata WEST BENGAL 700099 India |
| Phone |
9830430936 |
| Fax |
|
| Email |
arghya.mukherjee5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Soumya Jha |
| Designation |
Junior Consultant Department Of Onco Anaesthesia And Peri Operative Care |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Room No 2
Department of Onco Anaesthesia
Oncology Building
Medica Superspecialty Hospital
127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal 700099
Kolkata WEST BENGAL 700099 India |
| Phone |
8240874755 |
| Fax |
|
| Email |
jhasoumya6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sayantan Saha |
| Designation |
Fellow Resident Department Of Onco Anaesthesia And Peri Operative Care |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Room No 2
Department of Onco Anaesthesia
Oncology Building
Medica Superspecialty Hospital
127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal 700099
Kolkata WEST BENGAL 700099 India |
| Phone |
8918041617 |
| Fax |
|
| Email |
sayantan.saha808@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco Anaesthesia
Oncology Building
Medica Superspecialty Hospital
127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal 700099 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Arghya Mukherjee |
Medica Superspecialty Hospital |
Room No 2
Department of Onco Anaesthesia
Oncology Building
Medica Superspecialty Hospital
127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal 700099 Kolkata WEST BENGAL |
9830430936
arghya.mukherjee5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICAL RESEARCH ETHICS COMMITTEE-MEDICA SUPERSPECIALITY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society Of Anaesthesiologits Status I II or III
Scheduled to undergo elective major abdominal onco surgery requiring tracheal intubation |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient who had any pre existing moderate or severe heart or lung disease
Patient who will be having any intra operative pulmonary complication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the incidence and types of pulmonary complications detected using ultrasonography in the post operative period after major abdominal onco surgery |
At baseline that is prior ot before induction, after induction intra operative period ,after extubation and at 24 hour after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the feasibilty & practicality of routine bedside lung ultrasonography in the post operative setting |
At baseline that is prior ot before induction after induction intra operative period after extubation & at 24 hour after extubation |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
05/08/2025 |
| 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="0" Months="7" 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
|
Ultrasonography USG has become increasingly recognized as a powerful tool in the early detection and management of postoperative pulmonary complications particularly following major abdominal surgeries
These surgeries often carry a high risk of respiratory compromise due to factors such as anesthesia pain-induced hypoventilation diaphragmatic dysfunction and prolonged immobility
PULMONARY COMPLICATIONS including atelectasis pneumonia pleural effusion pulmonary edema pneumothorax are associated with increased morbidity, longer hospital stays and higher healthcare costs
Traditionally chest X rays and clinical evaluation have been the mainstay for diagnosing complications however these methods may lack sensitivity or be delayed especially in critically ill patients
In contrast USG offers several advantages it is portable repeatable free of ionizing radiation and allows dynamic assessment at the bedside Lung ultrasound can detect subtle changes in lung aeration visualize pleural movement and identify fluid collections with high sensitivity and specificity
USG can be particularly beneficial in the immediate postoperative period when rapid decision-making is essential and patient transport for imaging may be risky It enables clinicians to differentiate between various causes of respiratory distress and tailor interventions accordingly such as fluid management physiotherapy or antibiotic therapy As evidence supporting its use continues to grow USG is increasingly being integrated into perioperative care protocols as a frontline diagnostic modality for post operative pulmonary complications
|