| 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
|
|
|
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
|
|
|
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. |
|