Blood PressureNCT04736862
Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery
A study testing Continuous non-invasive blood pressure monitoring and Intermittent non-invasive blood pressure monitoring in people with Blood Pressure and Perioperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Blood Pressure, Perioperative Hypotension
- What is being tested?
- Continuous non-invasive blood pressure monitoring and Intermittent non-invasive blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2021to 6 Oct 2021
- 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
- Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.
Who cannot join
- Emergency surgery,
- pregnancy,
- American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.
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: The Impact of Continuous Non-invasive Blood Pressure Monitoring on Post-induction and Intraoperative Hypotension in Patients Having Non-cardiac Surgery (DETECT Trial): A Randomized Trial
This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP <65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.
Read the detailed description
not provided
- Conditions
- Blood Pressure, Perioperative Hypotension
- Being tested
- Continuous non-invasive blood pressure monitoring, Intermittent non-invasive blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous non-invasive blood pressure monitoringDevice
In patients randomized to the continuous monitoring group, continuous non-invasive finger-cuff blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry.
Intermittent non-invasive blood pressure monitoringDevice
In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring using upper-arm cuff oscillometry will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous non-invasive finger-cuff blood pressure monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Continuous monitoring group | Experimental | Not described Receives: Device: Continuous non-invasive blood pressure monitoring |
| Intermittent monitoring group | Active comparator | Not described Receives: Device: Intermittent non-invasive blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.
Measured: 15 min
Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start23 Mar 2021
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
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 Blood PressureStudies 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
- Care provider
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Kouz, M.D., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736862
- Sponsor's protocol ID
- PV7361
- Status last verified
- Oct 2021
- First submitted
- 31 Jan 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kouz K, Weidemann F, Naebian A, Lohr A, Bergholz A, Thomsen KK, Krause L, Petzoldt M, Moll-Khosrawi P, Sessler DI, Flick M, Saugel B. Continuous Finger-cuff versus Intermittent Oscillometric Arterial Pressure Monitoring and Hypotension during Induction of Anesthesia and Noncardiac Surgery: The DETECT Randomized Trial. Anesthesiology. 2023 Sep 1;139(3):298-308. doi: 10.1097/ALN.0000000000004629.
PubMed 37265355
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Non-invasive Blood Pressure Monitoring on Post-induction and Intraoperative Hypotension in Patients Having Non-cardiac Surgery (DETECT Trial): A Randomized Trial
- ClinicalTrials.gov ID
- NCT04736862
- Acronym / sponsor ID
- PV7361
- Conditions
- Blood Pressure, Perioperative Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 3 Feb 2021 (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 non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP <65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.
Detailed description
not provided
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous monitoring group | Experimental | Device: Continuous non-invasive blood pressure monitoring |
| Intermittent monitoring group | Active comparator | Device: Intermittent non-invasive 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 (1 listed)
- Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.
Key exclusion criteria (3 listed)
- Emergency surgery,
- pregnancy,
- American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.
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 non-invasive blood pressure monitoringIn patients randomized to the continuous monitoring group, continuous non-invasive finger-cuff blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry. | Device | Continuous monitoring group |
| Intermittent non-invasive blood pressure monitoringIn patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring using upper-arm cuff oscillometry will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous non-invasive finger-cuff blood pressure monitoring. | Device | Intermittent monitoring group |
Primary outcome
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time frame: 15 min
Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.
Time frame: intraoperative
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 12 Oct 2021.
- Derived from this study: PubMed 37265355Kouz K, Weidemann F, Naebian A, Lohr A, Bergholz A, Thomsen KK, Krause L, Petzoldt M, Moll-Khosrawi P, Sessler DI, Flick M, Saugel B. Continuous Finger-cuff versus Intermittent Oscillometric Arterial Pressure Monitoring and Hypotension during Induction of Anesthesia and Noncardiac Surgery: The DETECT Randomized Trial. Anesthesiology. 2023 Sep 1;139(3):298-308. doi: 10.1097/ALN.0000000000004629.
- 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.
Karim Kouz, M.D. 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 Continuous non-invasive blood pressure monitoring and Intermittent non-invasive blood pressure monitoring in people with Blood Pressure and Perioperative 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 1 inclusion and 3 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 12 Oct 2021. 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?
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group. (time frame: 15 min). The study lists 2 primary outcomes in all. 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 NCT04736862, 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 12 Oct 2021.