NCT03184285

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 3, 2017

Last Update Submit

June 9, 2017

Conditions

Bariatric SurgeryArterial Blood Pressure

Keywords

limitation in conventional monitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Procedure: baseline alert 1Procedure: Anti-Trendelenburg-position (ATB)Procedure: ATB in narcosisProcedure: baseline in narcosis 1Procedure: passive leg raisingProcedure: volume bolus substitutionProcedure: baseline in narcosis 2Procedure: start capnoperitoneumProcedure: ATB plus capnoperitoneumProcedure: ATB plus capnoperitoneum plus volume bolus substitutionProcedure: ATB loss of capnoperitoneumProcedure: baselineProcedure: baseline alert 2Procedure: torso position rising 30° at the beginningProcedure: torso position rising 30° at the end

Interventions

baseline alert 1PROCEDURE

measurement in supine position

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
Anti-Trendelenburg-position (ATB)PROCEDURE

measurement under ATB

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
ATB in narcosisPROCEDURE

measurement under ATB in narcosis

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
baseline in narcosis 1PROCEDURE

measurement in supine position in narcosis

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
passive leg raisingPROCEDURE

measurement under passive leg raising

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
volume bolus substitutionPROCEDURE

measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
baseline in narcosis 2PROCEDURE

measurement in supine position

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
start capnoperitoneumPROCEDURE

measurement in supine position

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
ATB plus capnoperitoneumPROCEDURE

measurement under ATB plus capnoperitoneum

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
ATB plus capnoperitoneum plus volume bolus substitutionPROCEDURE

measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
ATB loss of capnoperitoneumPROCEDURE

measurement under ATB

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
baselinePROCEDURE

measurement in supine position

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
baseline alert 2PROCEDURE

measurement in supine position

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
torso position rising 30° at the beginningPROCEDURE

measurement in the recovery unit

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery
torso position rising 30° at the endPROCEDURE

measurement in the recovery unit

Also known as: Device, Nexfin© vs FloTrac© vs sphygmomanometric blood pressure
bariatric surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, 24105, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35346046DERIVED

MeSH Terms

Interventions

Equipment and SuppliesBaseLine dental cement

Study Officials

  • Jochen Renner, PD Dr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 3, 2017

First Posted

June 12, 2017

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)