Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607211
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Cerebral Hypoperfusion at Transcranial Color-Coded Doppler
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cerebral Hypoperfusion at Transcranial Color-Coded Doppler Effects of a Treatment Protocol in Patients With Acute Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPOPERT
Brief Summary:
Background Cerebral ischemia is a major secondary factor contributing to worsening outcomes in patients with acute brain injuries Transcranial Color-Coded Doppler TCCD is a reliable method for evaluating cerebral perfusion and is recommended for use in emergency settings to reduce secondary injuries However there is no established treatment protocol for managing cerebral hypoperfusion as detected by TCCD
Objective The primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize TCCD parameters in patients with cerebral hypoperfusion The secondary objective is to investigate the concordance between invasive intracranial pressure ICP measurements and those estimated through TCCD using the Czosnyka formula
Methods This prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings Inclusion criteria include age over 18 Glasgow Coma Scale 9 and evidence of cerebral hypoperfusion based on TCCD performed on M1 tract of at least one middle cerebral artery The hypoperfusion is defined as the concurrent presence of at least two of the following parameters mean velocity below 30 cms diastolic velocity below 20 cms pulsatility index above 14
Patients will undergo a stepwise treatment approach involving normocapnia verification autoregulation testing increasing mean arterial pressure by 10 mmHg and hyperosmolar therapy The effectiveness of each intervention will be assessed by TCCD readings
Endpoints The primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol The secondary endpoint is the concordance between invasive ICP measurements and those estimated through TCCD
Sample Size The study aims to recruit 100 patients over 24 months Data analysis will include descriptive statistics with significant results considered at p 005
Objective The primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize TCCD parameters in patients with cerebral hypoperfusion The secondary objective is to investigate the concordance between invasive intracranial pressure ICP measurements and those estimated through TCCD using the Czosnyka formula
Methods This prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings Inclusion criteria include age over 18 Glasgow Coma Scale 9 and evidence of cerebral hypoperfusion based on TCCD performed on M1 tract of at least one middle cerebral artery The hypoperfusion is defined as the concurrent presence of at least two of the following parameters mean velocity below 30 cms diastolic velocity below 20 cms pulsatility index above 14
Patients will undergo a stepwise treatment approach involving normocapnia verification autoregulation testing increasing mean arterial pressure by 10 mmHg and hyperosmolar therapy The effectiveness of each intervention will be assessed by TCCD readings
Endpoints The primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol The secondary endpoint is the concordance between invasive ICP measurements and those estimated through TCCD
Sample Size The study aims to recruit 100 patients over 24 months Data analysis will include descriptive statistics with significant results considered at p 005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None