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Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial

NCT ID: NCT06753097

Last Updated: 2025-02-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

930 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-02-28

Brief Summary

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This is a randomized trial (1) investigating whether continuous finger-cuff - compared to intermittent oscillometric - arterial pressure monitoring reduces the amount of intraoperative hypotension (specifically, from the start of induction of general anesthesia until the end of surgery) in low-to-moderate risk patients having elective non-cardiac surgery.

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Detailed Description

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not provided

Conditions

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Intraoperative 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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Intermittent oscillometric arterial pressure monitoring

In patients assigned to intermittent oscillometric arterial pressure monitoring, oscillometric arterial pressure measurements will be displayed on the patient monitor and the treating anesthesiologist will be blinded to continuous finger-cuff arterial pressure monitoring. Oscillometric arterial pressure monitoring will be performed in 2.5 minutes intervals, but clinicians are free to perform additional measurements at any time.

Group Type NO_INTERVENTION

No interventions assigned to this group

Continuous finger-cuff arterial pressure monitoring

In patients assigned to continuous finger-cuff arterial pressure monitoring, arterial pressure waveforms and measurements from the finger-cuff will be displayed on the patient monitor and treating anesthesiologists will be blinded to intermittent oscillometric arterial pressure monitoring.

Group Type EXPERIMENTAL

Continuous finger-cuff arterial pressure monitoring

Intervention Type DEVICE

Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

Interventions

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Continuous finger-cuff arterial pressure monitoring

Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* Emergency surgery
* Patients on renal replacement therapy
* Contraindications for finger-cuff monitoring (e.g., Raynaud disease)
Minimum Eligible Age

18 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

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bernd Saugel, MD

Role: CONTACT

[email protected]
+49741052415

Karim Kouz, MD

Role: CONTACT

[email protected]
+49741052415

Facility Contacts

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Karim Kouz, MD

Role: primary

[email protected]
+49741052416

Other Identifiers

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2024-101349-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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