HypotensionNCT06314074
2.5 Versus 5 Minutes Trial
A study testing Oscillometric blood pressure monitoring at 2.5-minute intervals and Oscillometric blood pressure monitoring at 5-minute intervals in people with Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Oscillometric blood pressure monitoring at 2.5-minute intervals and Oscillometric blood pressure monitoring at 5-minute intervals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteGermany
- Study dates
- 12 Mar 2024to 31 Oct 2024
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Oscillometric Blood Pressure Measurement At 2.5- Vs. 5-minute Intervals and Hypotension in Patients Having Non-cardiac Surgery: a Randomized Trial
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.
- Conditions
- Hypotension
- Being tested
- Oscillometric blood pressure monitoring at 2.5-minute intervals, Oscillometric blood pressure monitoring at 5-minute intervals
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillometric blood pressure monitoring at 2.5-minute intervalsOther
Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.
Oscillometric blood pressure monitoring at 5-minute intervalsOther
Oscillometric blood pressure will be measured at 5-minute intervals during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Oscillometric blood pressure monitoring at 2.5-minute intervals | Experimental | 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. Receives: Other: Oscillometric blood pressure monitoring at 2.5-minute intervals |
| Oscillometric blood pressure monitoring at 5-minute intervals | Active comparator | 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. Receives: Other: Oscillometric blood pressure monitoring at 5-minute intervals |
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
The primary endpoint will be the time-weighted average mean arterial pressure <65 mmHg (continuous outcome) - defined as the area under a MAP of 65 mmHg divided by the time of continuous finger-cuff blood pressure monitoring [mmHg].
Measured: Beginning of surgery until the end of surgery
Secondary outcomes (2)
Episodes of a mean arterial pressure <50 mmHg
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 mmHg.
Measured: Beginning of surgery until the end of surgery
Norepinephrine dose
Time-weighted cumulative amount of norepinephrine indexed to body weight [µg/kg/min].
Measured: Beginning of surgery 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 posted15 Mar 2024
- Study start12 Mar 2024
- Primary completion24 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Kouz, University of Hamburg-Eppendorf
- Investigators
- Karim Kouz, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314074
- Sponsor's protocol ID
- 2023-101143-BO-ff
- Other IDs
- 2023
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kouz K, Sierzputowski P, Turan A, Flick M, Muller DX, Thomsen KK, Wegge M, Krause L, Bergholz A, Saugel B. Intervals for Oscillometric Arterial Pressure Monitoring during Noncardiac Surgery: The "2.5-Minute versus 5-Minute" Randomized Clinical Trial. Anesthesiology. 2026 Aug 1;145(2):291-299. doi: 10.1097/ALN.0000000000006140. Epub 2026 May 8.
PubMed 42102346
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillometric Blood Pressure Measurement At 2.5- Vs. 5-minute Intervals and Hypotension in Patients Having Non-cardiac Surgery: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06314074
- Acronym / sponsor ID
- 2023-101143-BO-ff
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 15 Mar 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oscillometric blood pressure monitoring at 2.5-minute intervals | Experimental | Other: Oscillometric blood pressure monitoring at 2.5-minute intervalsIn 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. |
| Oscillometric blood pressure monitoring at 5-minute intervals | Active comparator | Other: Oscillometric blood pressure monitoring at 5-minute intervalsIn 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Oscillometric blood pressure monitoring at 2.5-minute intervalsOscillometric blood pressure will be measured at 2.5-minute intervals during surgery. | Other | Oscillometric blood pressure monitoring at 2.5-minute intervals |
| Oscillometric blood pressure monitoring at 5-minute intervalsOscillometric blood pressure will be measured at 5-minute intervals during surgery. | Other | Oscillometric blood pressure monitoring at 5-minute intervals |
Primary outcome
Time-weighted average mean arterial pressure <65 mmHg
Time frame: Beginning of surgery until the end of surgery
The primary endpoint will be the time-weighted average mean arterial pressure <65 mmHg (continuous outcome) - defined as the area under a MAP of 65 mmHg divided by the time of continuous finger-cuff blood pressure monitoring [mmHg].
2 secondary outcomes
Episodes of a mean arterial pressure <50 mmHg
Time frame: Beginning of surgery until the end of surgery
Norepinephrine dose
Time frame: Beginning of surgery 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 25 Nov 2024.
- Derived from this study: PubMed 42102346Kouz K, Sierzputowski P, Turan A, Flick M, Muller DX, Thomsen KK, Wegge M, Krause L, Bergholz A, Saugel B. Intervals for Oscillometric Arterial Pressure Monitoring during Noncardiac Surgery: The "2.5-Minute versus 5-Minute" Randomized Clinical Trial. Anesthesiology. 2026 Aug 1;145(2):291-299. doi: 10.1097/ALN.0000000000006140. Epub 2026 May 8.
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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.
Karim Kouz, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillometric blood pressure monitoring at 2.5-minute intervals and Oscillometric blood pressure monitoring at 5-minute intervals in people with 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 25 Nov 2024. 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: Beginning of surgery 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?
On the ClinicalTrials.gov record for NCT06314074, which also lists 1 linked publication.
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 25 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.