Intraoperative HypotensionDETECT IINCT06753097
Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial
A study testing Continuous finger-cuff arterial pressure monitoring in people with Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Continuous finger-cuff arterial pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
We will include three types of patients:
- Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes
- Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
not provided
- Conditions
- Intraoperative Hypotension
- Being tested
- Continuous finger-cuff arterial pressure monitoring
- Keywords
- finger-cuff, blood pressure, intraoperative hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous finger-cuff arterial pressure monitoringDevice
Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent oscillometric arterial pressure monitoring | No intervention | 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. |
| Continuous finger-cuff arterial pressure monitoring | Experimental | 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. Receives: Device: Continuous finger-cuff arterial pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average mean arterial pressure <65 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Secondary outcomes (12)
Time-weighted average mean arterial pressure <60 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure <50 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure <40 mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during the start of induction of general anesthesia until the end of surgery
Cumulative duration of a mean arterial pressure <65 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >100 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >110 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >120 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >140 mmHg
Measured: during the start of induction of general anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start6 Jan 2025
- Primary completion19 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Kouz, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753097
- Sponsor's protocol ID
- 2024-101349-BO-ff
- Acronym
- DETECT II
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial
- ClinicalTrials.gov ID
- NCT06753097
- Acronym / sponsor ID
- DETECT II / 2024-101349-BO-ff
- Conditions
- Intraoperative Hypotension
- Keywords
- finger-cuff, blood pressure, intraoperative hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
not provided
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent oscillometric arterial pressure monitoring | No intervention | –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. |
| Continuous finger-cuff arterial pressure monitoring | Experimental | Device: Continuous finger-cuff arterial pressure monitoringIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous finger-cuff arterial pressure monitoringArterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring. | Device | Continuous finger-cuff arterial pressure monitoring |
Primary outcome
Time-weighted average mean arterial pressure <65 mmHg
Time frame: during the start of induction of general anesthesia until the end of surgery
12 secondary outcomes
Time-weighted average mean arterial pressure <60 mmHg
Time frame: 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
Time-weighted average mean arterial pressure <40 mmHg
Time frame: 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
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
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
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
Cumulative duration of a mean arterial pressure <65 mmHg
Time frame: 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
Time-weighted average mean arterial pressure >110 mmHg
Time frame: 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
Time-weighted average mean arterial pressure >140 mmHg
Time frame: during the start of induction of general anesthesia until the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous finger-cuff arterial pressure monitoring in people with Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average mean arterial pressure <65 mmHg (time frame: during the start of induction of general anesthesia until the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.