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CTRI Number  CTRI/2026/01/100813 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   How lung ultrasound during surgery helps predict lung problems after surgery 
Scientific Title of Study   Observation Between Intraoperative Ventilatory Strategies and Postoperative Pulmonary Complications Using Lung Ultrasonographic Score and Diaphragmatic Excursion: 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 Bhumika Pathak 
Designation  Professor of Department of Anaesthesiology 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  112, Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India

Anand
GUJARAT
388325
India 
Phone  9904438877  
Fax    
Email  docbhum29@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachit Patel 
Designation  Consultant Intensivist of Department of Intensive Care Unit 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  112, Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India

Anand
GUJARAT
388325
India 
Phone  9726657062  
Fax    
Email  rachitjp@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Kirtan Vandra 
Designation  Resident Doctor of Department of Anaesthesiology 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  112, Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India

Anand
GUJARAT
388325
India 
Phone  9664855410  
Fax    
Email  drkirtanvandra@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna hospital,Pramukh swami medical college, Karamsad-388325, Anand, Gujarat,India  
 
Primary Sponsor  
Name  Shree Krishna Hospital Pramukh Swami Medical College 
Address  Shree Krishna hospital,Pramukh swami medical college, Karamsad-388325, Anand, Gujarat,India  
Type of Sponsor  Private medical college 
 
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 Bhumika Pathak  Shree Krishna Hospital  112, Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India
Anand
GUJARAT 		 9904438877

docbhum29@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand,Gujarat-388325   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Open or laparoscopic abdominal surgeries under general anesthesia and mechanical ventilation for more than 120 minutes.
BMI: 18.5-34.9
ASA(American Society of Anaesthesiology) physical status: I-III. 
 
ExclusionCriteria 
Details  Pre-existing lung conditions (advanced COPD, ILD, etc.).
Neuromuscular disorders affecting diaphragmatic function.
Oxygen therapy requirement at rest 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To perform lung scan using ultrasonography and measure LUS preoperatively and postoperatively in patients ventilated with different ventilatory strategies undergoing elective abdominal surgery.  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the type of ventilatory strategy with changes in lung ultrasonographic score and diaphragm excursion.
To identify which ventilatory strategy is associated with the lowest incidence of PPCs. 		 24 Months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   22/01/2026 
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 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 prospective observational study evaluates how different intraoperative ventilation modes affect lung aeration diaphragmatic movement and postoperative pulmonary complications in adult patients undergoing open or laparoscopic abdominal surgery under general anesthesia. Seventy six patients will be randomized into volume controlled pressure controlled and pressure controlled volume guaranteed ventilation groups. Lung ultrasound score and diaphragmatic excursion will be measured before surgery and one hour after extubation. Patients will be followed for seven days for pulmonary complications. The study aims to identify the most lung protective ventilation strategy and establish lung ultrasound as a bedside tool for early detection of postoperative pulmonary complications. 
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