Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184285
• Other study ID #: IN-BAR-02
• Status: Completed
• Phase: N/A
• First received: June 3, 2017
• Last updated: June 9, 2017
• Start date: June 1, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Blood Pressure
• Bariatric Surgery

Intervention

Procedure:
• baseline alert 1
measurement in supine position
• Anti-Trendelenburg-position (ATB)
measurement under ATB
• ATB in narcosis
measurement under ATB in narcosis
• baseline in narcosis 1
measurement in supine position in narcosis
• passive leg raising
measurement under passive leg raising
• volume bolus substitution
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
• baseline in narcosis 2
measurement in supine position
• start capnoperitoneum
measurement in supine position
• ATB plus capnoperitoneum
measurement under ATB plus capnoperitoneum
• ATB plus capnoperitoneum plus volume bolus substitution
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
• ATB loss of capnoperitoneum
measurement under ATB
• baseline
measurement in supine position
• baseline alert 2
measurement in supine position
• torso position rising 30° at the beginning
measurement in the recovery unit
• torso position rising 30° at the end
measurement in the recovery unit

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the beginning of surgery to admission to the PACU, approximately 4 hours