2.5 Versus 5 Minutes Trial

NCT ID: NCT06314074

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2024-10-31

Brief Summary

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This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery.

Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Oscillometric blood pressure monitoring at 2.5-minute intervals

In patients assigned to oscillometric blood pressure monitoring at 2.5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 2.5 minutes during surgery.

Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.

Group Type EXPERIMENTAL

Oscillometric blood pressure monitoring at 2.5-minute intervals

Intervention Type OTHER

Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.

Oscillometric blood pressure monitoring at 5-minute intervals

In patients assigned to oscillometric blood pressure monitoring at 5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 5 minutes during surgery.

Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.

Group Type ACTIVE_COMPARATOR

Oscillometric blood pressure monitoring at 5-minute intervals

Intervention Type OTHER

Oscillometric blood pressure will be measured at 5-minute intervals during surgery.

Interventions

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Oscillometric blood pressure monitoring at 2.5-minute intervals

Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.

Intervention Type OTHER

Oscillometric blood pressure monitoring at 5-minute intervals

Oscillometric blood pressure will be measured at 5-minute intervals during surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥45 years
* scheduled for elective non-cardiac surgery under general anesthesia
* planned oscillometric blood pressure monitoring with an upper-arm cuff
* American Society of Anesthesiologists physical status class II or higher

Exclusion Criteria

* emergency surgery
* arm or shoulder surgery
* pregnancy
* preoperative blood pressure differences between the right and left arm of more than 20 mmHg
* intraoperative invasive blood pressure monitoring
* previous preoperative peripheral nerve injury (such as diabetic neuropathy, carpal tunnel syndrome, or cervical radiculopathy)
* contraindication for continuous finger-cuff blood pressure monitoring (e.g., Raynaud's disease, arterial-venous shunts, or cardiac assist devices)
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Karim Kouz

Dr. Karim Kouz, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karim Kouz, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2023-101143-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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