| CTRI Number |
CTRI/2022/09/045844 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of two types of ventilatory methods on brain blood flow, oxygenation in brain and the change in pressure inside the skull. |
|
Scientific Title of Study
|
Effect of intraoperative lung protective ventilation on cerebral hemodynamics (cerebral blood flow assessment using transcranial doppler, cerebral oxygenation by NIRS and ICP
measurement using subdural catheter) in neurosurgical patients: a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarath Surendran |
| Designation |
DM Neuroanaesthesia Resident |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
DM Neuroanaesthesia Resident,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
DM Neuroanaesthesia Resident,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9400943357 |
| Fax |
|
| Email |
sarathpurapuzha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Manikandan |
| Designation |
Professor, Division of Neuroanaesthesia and Neurocritical care |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
Professor,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
Professor,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446334711 |
| Fax |
|
| Email |
kanmanis@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Manikandan |
| Designation |
Professor, Division of Neuroanaesthesia and Neurocritical care |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
Professor,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
Professor,
Division of Neuroanaesthesia and Neurocritical care,
Department of Anaesthesiology,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446334711 |
| Fax |
|
| Email |
kanmanis@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram,
pin:695011 |
|
|
Primary Sponsor
|
| Name |
SCTIMST |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| 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 Sarath Surendran |
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
DEPARTMENT OF ANAESTHESIOLOGY, NEUROANAESTHESIA DEVISION,SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY,
MEDICAL COLLEGE,
THIRUVANANTHAPURAM,PIN:695011
Thiruvananthapuram
KERALA |
9400943357
sarathpurapuzha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee(IEC Regn No.ECR/189/Inst/KL/2013/RR-21) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting adult patients undergoing craniotomy in supine position or anterior spinal surgery at Sree Chitra Tirunal Institute for Medical Sciences and Technology
2.Age 18-60 yrs.
3. ASA (American Society of Anaesthesiologists) class 1 and 2
4. GCS 15 prior to the surgery
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Craniotomies other than supine position
3. Spine surgeries in prone position
4. Recent respiratory infection
5. Patients with chronic lung disease or pulmonary infections 1 month before surgery
6. Acute respiratory failure (pneumonia, acute lung injury, ARDS)
7. Emergency surgery
8. Patients with clinical signs (head ache, vomiting, confusion, papilledema, pupillary asymmetry) or radiological signs (midline shift > 1cm, presence of hydrocephalus) of raised intracranial pressure preoperatively.
9. Long standing uncontrolled diabetes mellitus, systemic hypertension, cardiovascular disease, COPD
10. Patients with previous history of stroke, transient ischemic attacks
11. Obesity
12. ASA class 3,4,5 patients
13. Patients with subarachnoid haemorrhage, vasospasm
14. Pregnant and lactating mothers
15. Any abnormality in baseline NIRS and TCD values
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| : comparison of cerebral oxygenation (NIRS), cerebral blood flow and intracranial pressure during conventional tidal volume ventilation and lung protective type of mechanical ventilation in patients undergoing neurosurgical procedures. |
2 time points: conventional ventilation and lung protective ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : comparison of changes in systemic hemodynamics and dynamic ventilatory parameters during normal tidal volume and lung protective ventilation and its effect on cerebral hemodynamics in patients undergoing neurosurgical procedures. |
2 time points: conventional ventilation and lung protective ventilation |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
26/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will provide once published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective observational study which involves comparing changes in cerebral blood flow, cerebral oxygenation and ICP during lung protective ventilation in patients undergoing craniotomy and spine surgery. |