Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery

June 9, 2017 updated by: Dr. Jochen Renner, University Hospital Schleswig-Holstein

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bariatric surgery
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
Procedure: baseline alert 1
measurement in supine position
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: Anti-Trendelenburg-position (ATB)
measurement under ATB
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: ATB in narcosis
measurement under ATB in narcosis
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: baseline in narcosis 1
measurement in supine position in narcosis
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: passive leg raising
measurement under passive leg raising
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: volume bolus substitution
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: baseline in narcosis 2
measurement in supine position
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: start capnoperitoneum
measurement in supine position
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: ATB plus capnoperitoneum
measurement under ATB plus capnoperitoneum
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: ATB plus capnoperitoneum plus volume bolus substitution
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: ATB loss of capnoperitoneum
measurement under ATB
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: baseline
measurement in supine position
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: baseline alert 2
measurement in supine position
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: torso position rising 30° at the beginning
measurement in the recovery unit
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
Procedure: torso position rising 30° at the end
measurement in the recovery unit
Other Names:
  • Device
  • Nexfin© vs FloTrac© vs sphygmomanometric blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning of surgery to admission to the PACU, approximately 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Jochen Renner, PD Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 3, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IN-BAR-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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