Bariatric SurgeryNCT03184285
Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery
A study testing baseline alert 1, Anti-Trendelenburg-position (ATB) and ATB in narcosis in people with Bariatric Surgery and Arterial Blood Pressure, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat measurement methods for the determination of arterial blood pressure in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Arterial Blood Pressure
- What is being tested?
- baseline alert 1, Anti-Trendelenburg-position (ATB) and ATB in narcosis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2015to 1 Jun 2017
- 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
- Indication for bariatric surgery was made
- Classification according to the American Society of Anesthesiologists (ASA) 2-4
- Age > 18 years
- Elective laparoscopic surgery
- Written declaration of consent
- Body Mass Index > 30 kg / m²
Who cannot join
- atrial fibrillation
- cardiac arrhythmias
- aortic aneurysm > 4,5 cm
- Peripheral arterial occlusive desease grade 3-4
- age < 18 years
- missing or incorrect patient consent form
- cognitive or linguistic barriers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, 24105
About this study
Official title: Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.
Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat measurement methods for the determination of arterial blood pressure in patients undergoing bariatric surgery.
Read the detailed description
Comparison between non-invasive discontinuous blood pressure measurement using a sphygomanometric blood pressure cuff, and continuous non-invasive and invasive beat to beat blood pressure measurement methods(Nexfin© and FloTrac©).
Bariatric patients show limitations regarding the conventional monitoring options with ECG derivation, pulse oxymetric oxygen saturation and sphygmomanometric blood pressure measurement. From a clinical point of view this results in an invasive arterial blood pressure monitoring . In addition to that, intraoperative extreme changes of the patients position on the table combined with the applied pneumoperitoneum during the minimally invasive laparoscopic surgery can significantly influence the cardiovascular parameters. An invasive arterial blood pressure monitoring is able to reproduce the blood pressure by stroke, but it does not give any information about the cardiac output. The sphygmomanometric blood pressure measurement also entails the risk of insufficient detection of a hypotonic phase in the measurement. Additional monitoring systems are currently available, which are capable of measuring completely non-invasive or semi-invasively different cardiovascular parameters such as cardiac output (CO) and fluid responsiveness. In this study, the investigators will compare continuous and discontinuous cardiovascular monitoring procedures and their parameters. The measurements take place at specific times, under defined changes in the body position with the additional influence of the pneumoperitoneum.
These changes are recorded and compared at the same time during different measuring methods preoperatively, intraoperatively and postoperatively. The non-invasive Nexfin© Monitoring (Edwards Lifesciences) is to be evaluated and compared with further measurement methods (FloTrac© (Edwards Lifesciences)) as well as the sphygmomanometric upper arm blood pressure measurement. The investigators also compare the non-invasive and invasive continuous beat to beat blood pressure measurement with conventional, discontinuous sphygomanometric upper arm blood pressure measurement.
The planned study is the comparison of 3 different hemodynamic monitoring procedures. For the evaluation the investigators use the method described by Bland and Altmann for calculating the mean deviation (bias) and the precision (mean value ± 2 standard deviations. In the case of multiple measurements , the modification of the Bland-Altman method is applied (repeated measurements). The number of cases was determined with n = 60 patients, followed by an intermediate evaluation. For a Bland-Altman analysis, the width w of the confidence interval for the Limits of Agreement is calculated as w = 6.79 • σ • 1 / √n, where n is number of cases and σ is the standard deviation. For a case count of n = 60, the result is w = 0.88 • σ and thus for this explorative study a sufficiently large number. In case of the dynamic variables, the percentage matching and the calculation of the kappa index are also used for the statistical evaluation.
- Conditions
- Bariatric Surgery, Arterial Blood Pressure
- Being tested
- baseline alert 1, Anti-Trendelenburg-position (ATB), ATB in narcosis, baseline in narcosis 1, passive leg raising
- Keywords
- limitation in conventional monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline alert 1Procedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position
Anti-Trendelenburg-position (ATB)Procedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement under ATB
ATB in narcosisProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement under ATB in narcosis
baseline in narcosis 1Procedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position in narcosis
passive leg raisingProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement under passive leg raising
volume bolus substitutionProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
baseline in narcosis 2Procedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position
start capnoperitoneumProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position
ATB plus capnoperitoneumProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement under ATB plus capnoperitoneum
ATB plus capnoperitoneum plus volume bolus substitutionProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
ATB loss of capnoperitoneumProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement under ATB
baselineProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position
baseline alert 2Procedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in supine position
torso position rising 30° at the beginningProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in the recovery unit
torso position rising 30° at the endProcedure or surgery
Also called Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
measurement in the recovery unit
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery | Experimental | baseline alert 1; Anti-Trendelenburg-position (ATB); Anti-Trendelenburg-position (ATB) in narcosis; baseline in narcosis 1; passive leg raising; volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); baseline in narcosis 2; start capnoperitoneum; Anti-Trendelenburg-position (ATB) plus capnoperitoneum; ATB plus capnoperitoneum plus volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); ATB loss of capnoperitoneum; baseline in narcosis; baseline alert 2; torso position rising 30° at the beginning; torso position rising 30° at the end Receives: Procedure: baseline alert 1; Procedure: Anti-Trendelenburg-position (ATB); Procedure: ATB in narcosis; Procedure: baseline in narcosis 1; Procedure: passive leg raising; Procedure: volume bolus substitution; Procedure: baseline in narcosis 2; Procedure: start capnoperitoneum; Procedure: ATB plus capnoperitoneum; Procedure: ATB plus capnoperitoneum plus volume bolus substitution; Procedure: ATB loss of capnoperitoneum; Procedure: baseline; Procedure: baseline alert 2; Procedure: torso position rising 30° at the beginning; Procedure: torso position rising 30° at the end |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive arterial blood pressure measurement in comparison to invasive measurement in bariatric surgery
Accuracy of non-invasive beat-to-beat blood pressure measurement and sphygmomanometric measure in comparison to the invasive Gold standard.
Measured: From the beginning of surgery to admission to the PACU, approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Jun 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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 Bariatric SurgeryStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jochen Renner, University Hospital Schleswig-Holstein
- Investigators
- Jochen Renner, PD Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184285
- Sponsor's protocol ID
- IN-BAR-02
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen J, Pohlmann M, Beckmann JH, Klose P, Gruenewald M, Renner J, Lorenzen U, Elke G. Comparison of oscillometric, non-invasive and invasive arterial pressure monitoring in patients undergoing laparoscopic bariatric surgery - a secondary analysis of a prospective observational study. BMC Anesthesiol. 2022 Mar 28;22(1):83. doi: 10.1186/s12871-022-01619-3.
PubMed 35346046
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.
- ClinicalTrials.gov ID
- NCT03184285
- Acronym / sponsor ID
- IN-BAR-02
- Conditions
- Bariatric Surgery, Arterial Blood Pressure
- Keywords
- limitation in conventional monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 12 Jun 2017 (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.
Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat measurement methods for the determination of arterial blood pressure in patients undergoing bariatric surgery.
Detailed description
Comparison between non-invasive discontinuous blood pressure measurement using a sphygomanometric blood pressure cuff, and continuous non-invasive and invasive beat to beat blood pressure measurement methods(Nexfin© and FloTrac©).
Bariatric patients show limitations regarding the conventional monitoring options with ECG derivation, pulse oxymetric oxygen saturation and sphygmomanometric blood pressure measurement. From a clinical point of view this results in an invasive arterial blood pressure monitoring . In addition to that, intraoperative extreme changes of the patients position on the table combined with the applied pneumoperitoneum during the minimally invasive laparoscopic surgery can significantly influence the cardiovascular parameters. An invasive arterial blood pressure monitoring is able to reproduce the blood pressure by stroke, but it does not give any information about the cardiac output. The sphygmomanometric blood pressure measurement also entails the risk of insufficient detection of a hypotonic phase in the measurement. Additional monitoring systems are currently available, which are capable of measuring completely non-invasive or semi-invasively different cardiovascular parameters such as cardiac output (CO) and fluid responsiveness. In this study, the investigators will compare continuous and discontinuous cardiovascular monitoring procedures and their parameters. The measurements take place at specific times, under defined changes in the body position with the additional influence of the pneumoperitoneum.
These changes are recorded and compared at the same time during different measuring methods preoperatively, intraoperatively and postoperatively. The non-invasive Nexfin© Monitoring (Edwards Lifesciences) is to be evaluated and compared with further measurement methods (FloTrac© (Edwards Lifesciences)) as well as the sphygmomanometric upper arm blood pressure measurement. The investigators also compare the non-invasive and invasive continuous beat to beat blood pressure measurement with conventional, discontinuous sphygomanometric upper arm blood pressure measurement.
The planned study is the comparison of 3 different hemodynamic monitoring procedures. For the evaluation the investigators use the method described by Bland and Altmann for calculating the mean deviation (bias) and the precision (mean value ± 2 standard deviations. In the case of multiple measurements , the modification of the Bland-Altman method is applied (repeated measurements). The number of cases was determined with n = 60 patients, followed by an intermediate evaluation. For a Bland-Altman analysis, the width w of the confidence interval for the Limits of Agreement is calculated as w = 6.79 • σ • 1 / √n, where n is number of cases and σ is the standard deviation. For a case count of n = 60, the result is w = 0.88 • σ and thus for this explorative study a sufficiently large number. In case of the dynamic variables, the percentage matching and the calculation of the kappa index are also used for the statistical evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery | Experimental | Procedure: baseline alert 1, Procedure: Anti-Trendelenburg-position (ATB), Procedure: ATB in narcosis, Procedure: baseline in narcosis 1, Procedure: passive leg raising, Procedure: volume bolus substitution, Procedure: baseline in narcosis 2, Procedure: start capnoperitoneum, Procedure: ATB plus capnoperitoneum, Procedure: ATB plus capnoperitoneum plus volume bolus substitution, Procedure: ATB loss of capnoperitoneum, Procedure: baseline, Procedure: baseline alert 2, Procedure: torso position rising 30° at the beginning, Procedure: torso position rising 30° at the endbaseline alert 1; Anti-Trendelenburg-position (ATB); Anti-Trendelenburg-position (ATB) in narcosis; baseline in narcosis 1; passive leg raising; volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); baseline in narcosis 2; start capnoperitoneum; Anti-Trendelenburg-position (ATB) plus capnoperitoneum; ATB plus capnoperitoneum plus volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); ATB loss of capnoperitoneum; baseline in narcosis; baseline alert 2; torso position rising 30° at the beginning; torso position rising 30° at the end |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication for bariatric surgery was made
- Classification according to the American Society of Anesthesiologists (ASA) 2-4
- Age > 18 years
- Elective laparoscopic surgery
- Written declaration of consent
Key exclusion criteria (7 listed)
- atrial fibrillation
- cardiac arrhythmias
- aortic aneurysm > 4,5 cm
- Peripheral arterial occlusive desease grade 3-4
- age < 18 years
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 |
|---|---|---|
| baseline alert 1Also: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position | Procedure or surgery | bariatric surgery |
| Anti-Trendelenburg-position (ATB)Also: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement under ATB | Procedure or surgery | bariatric surgery |
| ATB in narcosisAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement under ATB in narcosis | Procedure or surgery | bariatric surgery |
| baseline in narcosis 1Also: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position in narcosis | Procedure or surgery | bariatric surgery |
| passive leg raisingAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement under passive leg raising | Procedure or surgery | bariatric surgery |
| volume bolus substitutionAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous) | Procedure or surgery | bariatric surgery |
| baseline in narcosis 2Also: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position | Procedure or surgery | bariatric surgery |
| start capnoperitoneumAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position | Procedure or surgery | bariatric surgery |
| ATB plus capnoperitoneumAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement under ATB plus capnoperitoneum | Procedure or surgery | bariatric surgery |
| ATB plus capnoperitoneum plus volume bolus substitutionAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous) | Procedure or surgery | bariatric surgery |
| ATB loss of capnoperitoneumAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement under ATB | Procedure or surgery | bariatric surgery |
| baselineAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position | Procedure or surgery | bariatric surgery |
| baseline alert 2Also: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in supine position | Procedure or surgery | bariatric surgery |
| torso position rising 30° at the beginningAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in the recovery unit | Procedure or surgery | bariatric surgery |
| torso position rising 30° at the endAlso: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressuremeasurement in the recovery unit | Procedure or surgery | bariatric surgery |
Primary outcome
Non-invasive arterial blood pressure measurement in comparison to invasive measurement in bariatric surgery
Time frame: From the beginning of surgery to admission to the PACU, approximately 4 hours
Accuracy of non-invasive beat-to-beat blood pressure measurement and sphygmomanometric measure in comparison to the invasive Gold standard.
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 Jun 2017.
- Derived from this study: PubMed 35346046Hansen J, Pohlmann M, Beckmann JH, Klose P, Gruenewald M, Renner J, Lorenzen U, Elke G. Comparison of oscillometric, non-invasive and invasive arterial pressure monitoring in patients undergoing laparoscopic bariatric surgery - a secondary analysis of a prospective observational study. BMC Anesthesiol. 2022 Mar 28;22(1):83. doi: 10.1186/s12871-022-01619-3.
- 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.
Jochen Renner, PD Dr. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing baseline alert 1, Anti-Trendelenburg-position (ATB) and ATB in narcosis in people with Bariatric Surgery and Arterial Blood Pressure, run by University Hospital Schleswig-Holstein 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 6 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 12 Jun 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?
Non-invasive arterial blood pressure measurement in comparison to invasive measurement in bariatric surgery (time frame: From the beginning of surgery to admission to the PACU, approximately 4 hours). 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 NCT03184285, 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 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.