| CTRI Number |
CTRI/2023/04/051374 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound to see if patients who have undergone neurosurgery can breathe on their own without ventilator support |
|
Scientific Title of Study
|
Role of diaphragm, lung, and cardiac ultrasound in predicting weaning outcome in post operative mechanically ventilated neurosurgical patients: A prospective observational study
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavani B |
| Designation |
Senior Resident |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Institute |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block, GB Pant Hospital,
1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi
Central
DELHI
110002
India |
| Phone |
9840494620 |
| Fax |
|
| Email |
swathabhavani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragati Ganjoo |
| Designation |
Director Professor |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Institute |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block, GB Pant Hospital,
1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi
Central
DELHI
110002
India |
| Phone |
9718599407 |
| Fax |
|
| Email |
pganjoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Ganjoo |
| Designation |
Director Professor |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Institute |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block, GB Pant Hospital,
1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi
Central
DELHI
110002
India |
| Phone |
9718599407 |
| Fax |
|
| Email |
pganjoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute of Post graduate Medical Education and Research Institute |
| Address |
department of Anaesthesiology and Intensive care,
1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi, Delhi-110002 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhavani B |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Reaserch Institute |
Neuroanaesthesia Unit, Department of Anaesthesia and Intensive care,
A Block, ICU-16,
1, Jawaharlal Marg, 64 Khamba,
Raj Ghat, New Delhi,
Delhi-110002
Central
DELHI |
9840494620
swathabhavani@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL (LOK NAYAK, GB PANT HOSPITAL, GURU NANAK EYE CENTER) INSTITUTIONAL ETHICS COMMITEE |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound examination of diaphragm, lung and cardiac function |
Patients recruited for the study based on inclusion criteria will be evaluated with the Weaning Clinical Criteria.
Those patients deemed ready for weaning will be subjected to Spontaneous Breathing Trial which is spontaneous breathing through a T-tube circuit with oxygen flow at 5 L/min for 60 min. Patients who tolerate 60 mins of SBT will be continued on spontaneous breathing and will be observed for 48 hours thereafter for requirement of ventilatory support. They will be considered to have been successfully weaned if they do not require ventilatory support. Others who do not tolerate SBT would be connected back to ventilator and considered to have failed weaning.
USG examination will be performed at 5 min and 30 min of start of SBT
Parameters to be studied: a) Diaphragmatic thickening fraction, b) Diaphragmatic excursion,
c) Lung ultrasound score, d) Left ventricular diastolic function
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients, 18 to 65 years of age who have undergone neurosurgical procedure, and are on mechanical ventilation for more than 24 hours post operatively and are ready for weaning (based on Weaning Clinical Criteria) will be included in this study. |
|
| ExclusionCriteria |
| Details |
1) preoperatively patients who are on respiratory support for more than 24 hours (either intermittent or continuous oxygen therapy/ invasive or non-invasive mechanical ventilation)
2) patients with heart diseases like severe valvular heart diseases, severe left ventricular dysfunction ( EF<30%), heart failure, etc
3) patients who have undergone thoracic surgeries like pneumonectomy, pleurodesis, and thoracic trauma
4) pregnancy
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Diaphragmatic thickening fraction (DTF)
2. Diaphragmatic excursion (DE)
3. Lung ultrasound score (LUS)
4. Left ventricular (LV) diastolic function- E/A ratio
|
USG examination will be performed at 5 min and 30 min of start of Spontaneous Breathing Trial |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
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Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
10/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study aims to analyse the predictability of ultrasound-based parameters of lung, diaphragm and heart for the weaning outcome in postoperative mechanically ventilated neurosurgical patients who are on mechanical ventilation for >24 hr. After assessing the eligibility for initiating weaning process by Weaning Clinical Criteria, the patients will be subjected to Spontaneous Breathing Trial (SBT) which is spontaneous breathing through a T-tube circuit with oxygen flow at 5 L/min for 60 min. Patients who tolerate 60 mins of SBT will be continued on spontaneous breathing and will be observed for 48 hours thereafter for requirement of ventilatory support. They will be considered to have been successfully weaned if they do not require ventilatory support. Others who do not tolerate SBT would be connected back to ventilator and considered to have failed weaning. Ultrasound examination will be performed at 5 min and 30 min of start of SBT to assess a) Diaphragmatic thickening fraction, b) Diaphragmatic excursion, c) Lung ultrasound score, d) Left ventricular diastolic function. Weaning Outcome (Success/ Failure) will be decided on the basis of result of SBT.
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