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Cerebral Hemodynamics During Sustained Intra-operative Hypotension

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05016648
Collaborator
(none)
50
Enrollment
1
Location
40.8
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective:

The objective of this study is to describe the physiology of the cerebral autoregulation over time during extreme low blood pressures (BP).

Study design:

This is a retrospective data collection study. During the Personalized External Aortic Root Support (PEARS) procedure extreme low blood pressures < 65 mmHg are medically induced. Hemodynamic and neurophysiologic data is for clinic purposes stored.

Study population:

All patients requiring a PEARS study at the Amsterdam University Medical Centers, location Amsterdam Medical Center (AMC).

Investigation:

Cerebral parameters during sustained low blood pressures are monitored with the transcranial doppler (TCD) for cerebral blood flow velocity (CBFV), near infrared spectroscopy (NIRS) for cerebral tissue oxygenation (rS02) and the electroencephalography (EEG) for the cerebral activity. Blood pressure waveforms are retrieved from an invasive arterial catheter. Besides, blood gasses during the low blood pressures and cardiac output, measured with a Schwan Ganz catheter are collected as well as electronic health records (EHR) (like age, gender and weight). All these devices are implemented as stated in the clinic protocol.

Main study parameters/endpoints:

The investigators will describe the cerebral autoregulation (CA) in several ways to retrieve a cut-off or lower limit of the CA where the regulation is either intact or impaired. First the static CA will be created with the mean arterial pressure (MAP) and mean cerebral blood flow (CBFm), second, the CA will be described with the mean flow velocity index (Mx, a method which calculates the correlation between the MAP and CBFm), COX (correlation between MAP and rS02) and with data of the EEG.

After retrieval of the cut off or lower limit, the CA below this point will be described over time to check for differences.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cerebral Hemodynamics During Sustained Intra-operative Hypotension
    Actual Study Start Date :
    Aug 7, 2019
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    PEARS patients

    Patients who underwent the personalized external aortic root support procedure at the AMC. Cerebral monitoring measurements (NIRS, EEG, TCD and blood pressure) are used for the study.

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral autoregulation [During the entire operation, about 4 hours.]

      A mechanism in the brain influenced by the cerebral blood pressure and cerebral blood flow velocity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Planned for a PEARS procedure

    • Informed consent should be given

    Exclusion Criteria:
    • No informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AUMC Amsterdam Noord-holland Netherlands 1100DD

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    D.P.Veelo, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05016648
    Other Study ID Numbers:
    • W20_244#20.270
    First Posted:
    Aug 23, 2021
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by D.P.Veelo, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    cerebral autoregulation
    PEARS
    Additional relevant MeSH terms:
    Hypotension

    Study Results

    No Results Posted as of Aug 27, 2021