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

March 6, 2026 updated by: Karim Kouz, Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

not provided

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
930

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Karim Kouz, MD
  • Phone Number: +49741052415
  • Email: k.kouz@uke.de

Study Locations

  • Germany
      • Hamburg, Germany
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

We will include three types of patients:

  1. Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes
  2. Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes
  3. Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes

We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned.

Patients that meet one or more of the following exclusion criteria cannot participate in the trial:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
Device: Continuous finger-cuff arterial pressure monitoring
Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time-weighted average mean arterial pressure <65 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time-weighted average mean arterial pressure <60 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure <50 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure <40 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <65 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <60 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <40 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Cumulative duration of a mean arterial pressure <65 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >100 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >110 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >120 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >140 mmHg
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: Up until the first postoperative day
Acute kidney injury (binary outcome) will be defined as an increase in postoperative serum creatinine from baseline of at least 0.3 mg/dl or ≥50%.
Up until the first postoperative day
Acute myocardial injury
Time Frame: Up until the first postoperative day
Acute myocardial injury (binary outcome) will be defined based on the definition of "myocardial injury and infarction associated with non-cardiac procedures" according to the Fourth Universal Definition of Myocardial Infarction (2018)
Up until the first postoperative day
Time-weighted average of the percentage decrease in regional cerebral oxygen saturation from the baseline
Time Frame: during the start of induction of general anesthesia until the end of surgery
during the start of induction of general anesthesia until the end of surgery
Incidence of cerebral hypoxia
Time Frame: during the start of induction of general anesthesia until the end of surgery
Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).
during the start of induction of general anesthesia until the end of surgery
Cumulative duration of cerebral hypoxia
Time Frame: during the start of induction of general anesthesia until the end of surgery
Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).
during the start of induction of general anesthesia until the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-101349-BO-ff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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