- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879330
NIRS Directed Optimal Cerebral Perfusion Pressure in Aneurysmal Subarachnoid Hemorrhage Patients: A Feasibility Study
June 11, 2019 updated by: Xiangya Hospital of Central South University
Neurologic dysfunction is common in aneurysmal subarachnoid hemorrhage (aSAH) patients.
As we know, after the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care.
Nonetheless, the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients: the Brain Trauma Foundation (BTF) guidelines recommend maintaining CPP between 60 and 70 mmHg; Some guidelines recognize that patients with a history of hypertension may require a higher MAP.
However, these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions.
Cerebral autoregulation is the mechanism that maintains cerebral blood supply, hence CBF approximately constant despite changes in MAP or, more precisely, despite changes in CPP.
Maintaining blood pressure within the cerebral blood flow (CBF) autoregulation range (termed "optimal MAP") is associated with improved outcomes for patients.
The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation range.
The most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index (PRx) that uses ICP as a surrogate for CBV.
However, assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas.
Alternatively, in the absence of invasive intracranial pressure monitoring to determine CPP, a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler (TCD)-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure (termed mean velocity index or Mx).
Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training, the results are operator-dependent.
Near-infrared spectroscopy (NIRS) measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index.
In contrast to TCD, the NIRS sensors are very easy to apply (the probes attach to the forehead with self-adhesive pads) and do not require frequent calibration making them more suitable for long-term monitoring.
Therefore, in this study, Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring.
The correlation curve between ORI/THx and blood pressure will be obtained through continuous monitoring of 2 hours.
According to the correlation curve, the optimal blood pressure which provides the optimal CPP will be determined.
Then the optimal blood pressure which CPP is within 5 mmHg of CPPopt will be maintained as the target of blood pressure management for the intervention group during ICU stay.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult (Age ≥ 18 years) aneurysmal subarachnoid hemorrhage patients (Hunt & Hess classification≥ 3) who admitted to ICU and predicted to stay in ICU ≥ 24 hours.
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Admitted to ICU because of aSAH (Hunt & Hess classification≥ 3).
- Predicted to stay in ICU ≥ 24 hours
Exclusion Criteria:
- Unable to perform NIRS monitoring because of anatomic factors: such as forehead skin damage, intracranial gas accumulation, severe edema of monitoring sites;
- Patients with severe organ failure: such as poorly controlled chronic hypertension, chronic renal failure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal CPP
Time Frame: 16 hours
|
the minimal time that CPPopt can be determined by the correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure.
|
16 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2019
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 15, 2019
First Posted (Actual)
March 18, 2019
Study Record Updates
Last Update Posted (Actual)
June 12, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018101083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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