Cerebral Hemodynamics During Sustained Intra-operative Hypotension

NCT05016648 | Unknown

• 1 other identifier: W20_244#20.270
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Autoregulation

Keywords

cerebral autoregulation; PEARS

Outcome Measures

Primary Outcomes (1)

• Cerebral autoregulation

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

  During the entire operation, about 4 hours.

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients planned for the PEARS procedure at the AMC.

You may qualify if:

• Planned for a PEARS procedure
• Informed consent should be given

You may not qualify if:

• No informed consent

Sponsors & Collaborators

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

Study Sites (1)

AUMC

Amsterdam, North Holland, 1100DD, Netherlands

RECRUITING

Central Study Contacts

Nicholaas H. Sperna Weiland, MD PhD

CONTACT

0031205669111; n.h.spernaweiland@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: August 7, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

NL (1)