Blood PressureNCT04894019
Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery
A study testing Continuous 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 invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Perioperative Hypotension, Postinduction Hypotension
- What is being tested?
- Continuous 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
- 16 May 2021to 23 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients...
- at least 18 years of age
- scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study
Who cannot join
- Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device)
- emergency surgery
- American Society of Anesthesiologists physical status classification V or VI
- need for femoral artery catheterization
- 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 Effect of Continuous Invasive Arterial Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery (AWAKE Trial): a Randomized Trial
This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.
Read the detailed description
not provided
- Being tested
- Continuous 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 invasive blood pressure monitoringDevice
Continuous invasive blood pressure monitoring using an arterial catheter
Intermittent non-invasive blood pressure monitoringDevice
Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry
| Study group | Role | What they receive |
|---|---|---|
| Continuous monitoring group | Experimental | In patients randomized to the continuous monitoring group, continuous invasive arterial 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. Receives: Device: Continuous invasive blood pressure monitoring |
| Intermittent monitoring group | Active comparator | In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous invasive arterial blood pressure monitoring. 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: during the induction period
Secondary outcomes (3)
Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group.
Measured: during the induction period
Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group.
Measured: during the induction period
Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group.
Measured: during the induction period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start16 May 2021
- Primary completion23 Nov 2021
- Study completion23 Nov 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894019
- Sponsor's protocol ID
- 2020-10057-BO-ff
- Status last verified
- Dec 2021
- First submitted
- 3 May 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.
PubMed 36008202
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Invasive Arterial Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery (AWAKE Trial): a Randomized Trial
- ClinicalTrials.gov ID
- NCT04894019
- Acronym / sponsor ID
- 2020-10057-BO-ff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 16 May 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 20 May 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 invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.
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 invasive blood pressure monitoringIn patients randomized to the continuous monitoring group, continuous invasive arterial 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 monitoring group | Active comparator | Device: Intermittent non-invasive blood pressure monitoringIn patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous invasive arterial blood pressure monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients...
- at least 18 years of age
- scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study
Key exclusion criteria (5 listed)
- Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device)
- emergency surgery
- American Society of Anesthesiologists physical status classification V or VI
- need for femoral artery catheterization
- 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 invasive blood pressure monitoringContinuous invasive blood pressure monitoring using an arterial catheter | Device | Continuous monitoring group |
| Intermittent non-invasive blood pressure monitoringIntermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry | 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: during the induction period
3 secondary outcomes
Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time frame: during the induction period
Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time frame: during the induction period
Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time frame: during the induction period
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 3 Dec 2021.
- Derived from this study: PubMed 36008202Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.
- 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 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 3 inclusion and 5 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 3 Dec 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: during the induction period). 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 NCT04894019, 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 3 Dec 2021.