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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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


 
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