| CTRI Number |
CTRI/2024/07/069939 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of hypotension with and without a novel blood pressure monitoring tool (Hypotension Prediction Index) in patients undergoing brain tumor removal surgery |
|
Scientific Title of Study
|
Comparison of intraoperative hypotension with and without hypotension prediction index tool in patients undergoing brain tumor surgery |
| 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 Thomas Francis |
| Designation |
Senior Resident (DM Neuroanaesthesia and Neurocritical Care) |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Senior Resident (DM Neuroanaesthesia and Neurocritical care)
Department of Neuroanaesthesia and Neurocritical Care,
NIMHANS, Bengaluru-560029
Bangalore
KARNATAKA
560029
India |
| Phone |
7000043320 |
| Fax |
|
| Email |
dr.thomasfrancis93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sriganesh K |
| Designation |
Professor & Head of Department |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Professor & Head of Department
Department of Neuroanaesthesia and Neurocritical Care
NIMHANS, Bengaluru-560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriganesh K |
| Designation |
Professor & Head of Department |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Professor & Head of Department
Department of Neuroanaesthesia and Neurocritical Care
NIMHANS, Bengaluru-560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS) Hosur Road Bangalore Karnataka India 560029 |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden)
Bangalore – 560029
Karnataka, India |
| 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 Thomas Francis |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Department of Neuroanaesthesia and Neurocritical Care, NIMHANS, Hosur Road, Bangalore, Karnataka-560029
Bangalore
KARNATAKA |
7000043320
dr.thomasfrancis93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neuro Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (3) ICD-10 Condition: C724||Malignant neoplasm of acoustic nerve, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional group |
Conventional management with the invasive blood pressure monitoring will be followed. Administration of fluids, vasopressors or inotropes will be guided by the hemodynamic parameters displayed on the standard anaesthesia monitor at the discretion of the attending anesthesiologist. |
| Intervention |
Hypotension Prediction Index software of Edward Lifesciences EV-1000 |
Patients in HPI group will have an additional Acumen FlorTrac transducer connected to an EV-1000 monitor with the HPI software. The HPI index ranges between 0 to 100. When the index reaches 85, the monitor alerts the operator and a secondary screen will be revealed. The secondary screen displays hemodynamic variables ( mean arterial pressure, heart rate, stroke volume, cardiac output, systolic slope, stroke volume variation and dynamic arterial elastance that provide information about the likely cause of the predicted hypotension and act accordingly.
The data is collected every minute from baseline till the end of the case. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 and 65 years of either gender. 2. American Society of Anesthesiologists physical status (ASA-PS) I and II patients. 3. Undergoing elective surgery for excision of brain tumors with or without intraoperative neuromonitoring. 4. With brain tumors of size more than 4 cms. 5. Anticipated intraoperative bleeding of more than 500mL. |
|
| ExclusionCriteria |
| Details |
1. Significant hypotension before surgey. 2. With known left or right cardiac failure. 3. With significant hypertension. 4. Arrhythmias (Atrial fibrillation), cardiac shunts, severe aortic stenosis. 5. Emergency surgery. 6. Surgery done in sitting position. 7. Pregnant women. 8. Refuse to give consent. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of intraoperative hypotension in both the HPI group and the conventional group |
Baseline followed by every minute till the end of the case. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time Weighted Average of intraoperative hypotension defined as the depth of hypotension with a fall in mean arterial pressure to less than 65mm Hg multiplied by the time spend with mean arterial pressure of less than 65mm Hg divided by the total duration of surgery |
Baseline followed by every minute till the end of the case. |
| Incidence of intraoperative hypotension, defined as the number of hypotensive events. A hypotensive event is defined as reduction of mean arterial pressure to less than 65 mm Hg for at least 1min. The hypotensive event will end when the MAP value is normalised. |
Baseline followed by every minute till the end of the case. |
| Severity of hypotension by calculating the time weighted average of intraoperative hypotension below 60mm Hg of MAP & below 55mm Hg of MAP between the two groups |
Baseline followed by every minute till the end of the case. |
| Compare the amount of intraoperative crystalloid & collloids, erythrocyte transfusions, cumulative dose of the vasoactive medications, anesthetic & analgesics, depth of anaesthesia values, blood loss & urine output between the two groups |
Baseline followed by every minute till the end of the case. |
| Compare the outcome measures- intraoperative vasopressor use, intraoperative myocardial ischemia ( ST segment values more than or less than 2mm), acute kidney injury ( changes in serum creatinine by more than 0.3mg% as per AKIN criteria), emergence ( Riker sedation agitation scale) & postoperative delirium ( confusion assessment method), new onset motor deficits ( perioperative stroke), length of ICU stay & duration of hospital stay. |
Baseline followed by every minute till the end of the case. |
| To calculate the cost effectiveness/financial burden with the use of HPI index |
Baseline followed by every minute till the end of the case. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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
|
Intraoperative hypotension (IOH) is a common and frequent side effect of anesthesia. Treatment of hypotension is currently reactive, which means that it starts after a hypotensive effect occurs. The type of treatment will depend on various hemodynamic variables that can be provided by basic or advanced monitoring techniques. However, even if these techniques can give detailed knowledge on the actual hemodynamic status of the patient, they cannot predict future hypotensive events. Therefore, hypotension will occur, and given that even brief episodes of intraoperative hypotension can be deleterious for the patient, the need for a prediction model becomes apparent.Values below a threshold of MAP below 60-70 mmHg are associated with myocardial injury, acute kidney injury, and death. The Hypotension Prediction Index algorithm on the EV 1000 system was developed by Hatib et al, with the help of machine learning. It uses 23 arterial waveform features to predict hypotension defined by MAP less than 65mm Hg for at least 1minute. The index values ranges from 0 to 100, with higher numbers reflecting a higher likelihood of subsequent hypotension. The index reportedly has 92% sensitivity and specificity for predicting hypotension 5minute in advance while sensitivity was 89% and specificity was 90% for 10min in advance and was 88% and 87% for 15min in advance. Therefore, with the use of HPI algorithm, hypotension can be theoretically predicted and subsequently prevented with adequate treatment.
We aim to evaluate the role of Hypotension Prediction Index integrated with a hemodynamic management protocol on intraoperative hypotension during brain tumor surgery and peri-operative complications. |