Blood Pressure Stability in General AnaesthesiaANIKOBNCT02519101
Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia
A study testing continuous noninvasive blood pressure monitoring ClearSight-Device in people with Blood Pressure Stability in General Anaesthesia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure Stability in General Anaesthesia
- What is being tested?
- continuous noninvasive blood pressure monitoring ClearSight-Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to May 2016
- 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
- orthopedic surgery in general anaesthesia
- American Society of Anesthesiologists - Physical Status (ASA) 2 or ASA 3
- arterial Hypertension
Who cannot join
- -invasive blood pressure monitoring required
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anaesthesiologie am Klinikum der Universität München
Munich, Bavaria, 81377
About this study
Official title: Impact of Continuous Noninvasive Arterial Blood Pressure Monitoring on Blood Pressure Stability During General Anaesthesia in Orthopedic Patients
Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension
- Being tested
- continuous noninvasive blood pressure monitoring ClearSight-Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous noninvasive blood pressure monitoring ClearSight-DeviceDevice
Also called ClearSight-Device (Edwards)
Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)
| Study group | Role | What they receive |
|---|---|---|
| Continunous blood pressure monitoring | Experimental | Patients receive continuous noninvasive blood pressure monitoring in addition to intermittent monitoring Receives: Device: continuous noninvasive blood pressure monitoring ClearSight-Device |
| Intermittent blood pressure monitoring | No intervention | Control group with intermittent blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Hypotensive Events in comparison between both groups
Measured: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Dosage of Norepinephrine given to the patient to maintain blood pressure normotensive
Measured: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Secondary outcomes (1)
Incidence of acute kidney failure postoperatively
Measured: during hospital stay after surgical procedure (in average 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
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 Pressure Stability in General AnaesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephan Czerner, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519101
- Sponsor's protocol ID
- 290-15
- Acronym
- ANIKOB
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.
PubMed 28922340
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Noninvasive Arterial Blood Pressure Monitoring on Blood Pressure Stability During General Anaesthesia in Orthopedic Patients
- ClinicalTrials.gov ID
- NCT02519101
- Acronym / sponsor ID
- ANIKOB / 290-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Aug 2015 (estimated)
- 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.
Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continunous blood pressure monitoring | Experimental | Device: continuous noninvasive blood pressure monitoring ClearSight-DevicePatients receive continuous noninvasive blood pressure monitoring in addition to intermittent monitoring |
| Intermittent blood pressure monitoring | No intervention | –Control group with intermittent 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)
- orthopedic surgery in general anaesthesia
- American Society of Anesthesiologists - Physical Status (ASA) 2 or ASA 3
- arterial Hypertension
Key exclusion criteria (1 listed)
- -invasive blood pressure monitoring required
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 noninvasive blood pressure monitoring ClearSight-DeviceAlso: ClearSight-Device (Edwards)Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device) | Device | Continunous blood pressure monitoring |
Primary outcome
Number of Patients with Hypotensive Events in comparison between both groups
Time frame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Dosage of Norepinephrine given to the patient to maintain blood pressure normotensive
Time frame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
1 secondary outcome
Incidence of acute kidney failure postoperatively
Time frame: during hospital stay after surgical procedure (in average 3 days)
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 30 Aug 2017.
- Derived from this study: PubMed 28922340Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.
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 noninvasive blood pressure monitoring ClearSight-Device in people with Blood Pressure Stability in General Anaesthesia, run by Ludwig-Maximilians - University of Munich 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 1 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 30 Aug 2017. 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?
Number of Patients with Hypotensive Events in comparison between both groups (time frame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)). 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 NCT02519101, 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 30 Aug 2017.