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Completed

NCT Number: NCT05283824

Comparison of 3 Techniques for Blood Pressure Measurements During Interventional Neuroradiology Procedures

Some observational studies demonstrated that hypotension was associated with post-operative morbidity. During neuroradiological procedures, cerebral perfusion pressure should be cautiously maintained and hypertension should also be avoided. So, a precise arterial pressure measurement is needed during this procedures. A continuous monitoring of arterial pressure needed the placement of an arterial catheter in radial artery. The placement of this catheter might be long, difficult and incompatible with emergency neuroradiological procedure (such as thrombectomy). Then, this invasive technique is associated with several minor and major side effects such as: pain, infection, thrombosis, hematoma.

The Clearsight®, commercialized by Edwards Life Science Company®, is a non invasive device which mesure continuously arterial pressure with Volume-Clamp method. In operating room, some studies found a good accuracy between Clearsight® and other invasive monitoring system. There is no description of the use of Clearsight® during neuroradiological procedures.

The investigators hypothesized that Clearsight® measurement of arterial pressure are concordant with arterial pressure measure with the placement of an arterial catheter. The investigators also plan to evaluate accuracy of intermittent non invasive pressure measurement with traditional cuff.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (Age > 18 years old)
  • Elective or emergent neuroradiological procedure under general or local anesthesia for : Endovascular treatment of cerebral aneurysms / arteriovenous malformation, Thrombectomy, Arteriography, transluminal balloon angioplasty for vasospasm
  • Placement of arterial catheter for the measurement of continuous arterial pressure

Exclusion criteria

  • Contraindication of placement of arterial catheter or digital cuff (Clearsight) such as: Reynaud syndrome, Buerger syndrome
  • Pregnant women
  • Refusal

Treatment and study plan

Primary outcomes

  1. Systolic arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of systolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)

  2. Diastolic arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of diastolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)

  3. Mean arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of mean arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)

Secondary outcomes

  1. Systolic arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of systolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)

  2. Diastolic arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of diastolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)

  3. Mean arterial blood pressure (mmHg)

    Time frame: During neuroradiological procedure

    The main objective of this study is to evaluate concordance of mean arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: NEXFIN-NRI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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