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CTRI Number  CTRI/2025/10/095627 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Role of Ultrasound to determine which patients will require a ventilator after major abdominal surgery 
Scientific Title of Study   Role of Diaphragmatic Ultrasound in predicting need for Postoperative Mechanical Ventilation after major Hepato-Pancreato-Biliary Procedures: 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  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room No 016133 Department of Anaesthesiology All India Institute of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room No 016133 Department of Anaesthesiology All India Institute of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand


UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room No 016133 Department of Anaesthesiology All India Institute of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand


UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rishikesh 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  Veerbhadra Road Near Barrage Sturida Colony Pahsulok Rishikesh Uttarakhand 249203 
Type of Sponsor  Research institution and hospital 
 
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 Deepak Singla  All India Institute of Medical Sciences Rishikesh  Room No 016133 Department of Anaesthesiology All India Institute of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand
Dehradun
UTTARANCHAL 
9068504999

deepak10.4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged more than 18 years, American society of Anaesthesia (ASA) class I to III, undergoing major hepato-pancreato-biliary procedures 
 
ExclusionCriteria 
Details  Refusal to consent
Patients with severely compromised lung function
Patients with any known cardiac disease
Patient already on mechanical ventilation
Patients in shock or altered mental status
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diaphragmatic weakness as assessed by ultrasound  After the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the diaphragmatic function from the preoperative period to post-operative period   After the surgery 
Change in the diaphragmatic function from the preoperative period to post-operative period with and without epidural  After the surgery 
Correlation of the diaphragmatic function with the need for post-operative mechanical ventilation   After the surgery 
Correlation of the diaphragmatic function with the lung ultrasound score and post-operative arterial blood gases (ABG).  After the surgery 
Correlation of diaphragmatic function with patient outcomes  Till 28 days 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Studies have shown that the diaphragm can be significantly weakened postoperatively because it is fatigued during invasive mechanical ventilation. A measurement of the twitch frequency changes  showed that there was an increased incidence of diaphragmatic weakness in patients having weaning failure.  The American Thoracic Society and the European Respiratory Society have put forth a list of tests that can be performed on a patient to assess diaphragmatic functioning. These include subjective tests like measuring airway opening pressure during sniffing or cough by the patient. Other tests that measure the true respiratory effort exerted by an individual are called volitional tests. Ultrasound assessment of diaphragm is a more feasible modality due to widespread availability of portable ultrasound.  

In Diaphragmatic Evaluation approach , a high-frequency linear ultrasound probe, is  applied below the nipple, at the anterior axillary line. In this approach A stands for axillary line, B stands for breathing as it is measured during breathing, and C stands for caudal direction in which the probe is moved to view the diaphragm. The thickness of the diaphragm and its ratio during inspiration and expiration show the amount of effort that is being exerted by the muscle. In normal individuals the change ranges from 28-96 percent and 35-5 percent in individuals with diaphragmatic paralysis.

So, perioperative assessment of diaphragm in patients undergoing major surgeries. 

However, despite thorough search of literature we could not find any study where diaphragm function is assessed during surgery in such patients. So, this study aims to analyze the association of diaphragmatic weakness in patients posted for Hepato-Pancreato-Biliary surgery under general anaesthesia, with need for postoperative mechanical ventilation. We hypothesize that perioperative diaphragmatic weakness will result in significantly increased need for postoperative mechanical ventilation.

 
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