NCT02690688

Brief Summary

Dynamic preload variables like pulse-pressure and stroke volume variation may be used to predict fluid responsiveness in patients during controlled ventilation. Previous work has shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic preload parameters, suggestive of a fluid deficit - despite fluid status had not changed \[van Lavieren M 2014\]. The results of this study are limited by the fact that a non-invasive and uncalibrated hemodynamic monitoring system (Nexfin™) was used. The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive surgical procedures with pneumoperitoneum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 18, 2016

Last Update Submit

February 18, 2016

Conditions

Pneumoperitoneum

Keywords

Pulse Pressure VariationNIRSPneumoperitoneumAbdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters

    Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery

Secondary Outcomes (2)

  • Influence of pneumoperitoneum or open abdominal surgery on cerebral oxymetry

    Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery

  • Correlation of cerebral oxymetry and cadiac index in pneumoperitoneum or open abdominal surgery

    Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery

Study Arms (2)

Pneumoperitoneum

Patients scheduled for laparoscopic (minimal invasive) abdominal surgery supported by pneumoperitoneum. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience

Device: determination of dynamic preload variables

Open Surgery

Patients scheduled for conventional (open) abdominal surgery. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience

Device: determination of dynamic preload variables

Interventions

determination of dynamic preload variablesDEVICE
Open SurgeryPneumoperitoneum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with the need of an abdominal operation. According operation technique patients gets assigned to one of the groups. In- and exculsion criteria are given below.

You may qualify if:

  • ASA I-III patient
  • Signed agreement
  • Surgical procedure with open abdomen surgery or pneumperitoneum
  • Age \> 18 Years
  • Intubation

You may not qualify if:

  • BMI ≥ 35 kg/m2
  • Need for catecholamines
  • Cardiac arrhythmia
  • Fluid resuscitation during measurements
  • Ongoing periduralcatheter-therapy
  • Missing agreement
  • Disposition for MH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University of Luebeck

Lübeck, 23568, Germany

Location

Related Publications (2)

  • van Lavieren M, Veelenturf J, Hofhuizen C, van der Kolk M, van der Hoeven J, Pickkers P, Lemson J, Lansdorp B. Dynamic preload indicators decrease when the abdomen is opened. BMC Anesthesiol. 2014 Oct 14;14:90. doi: 10.1186/1471-2253-14-90. eCollection 2014.

    PMID: 25337036BACKGROUND

  • Jacques D, Bendjelid K, Duperret S, Colling J, Piriou V, Viale JP. Pulse pressure variation and stroke volume variation during increased intra-abdominal pressure: an experimental study. Crit Care. 2011;15(1):R33. doi: 10.1186/cc9980. Epub 2011 Jan 19.

    PMID: 21247472BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Matthias Heringlake, MD

    Professor of Anesthesiology, Deputy Director Cardiac Anesthesia, Dept. of Anesthesiology University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Heringlake, MD

CONTACT

0049/451/500-2772matthias.heringlake@uksh.de

Patrick Kellner, MD

CONTACT

0049/451/500-2766patrick.kellner@uksh.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology, Deputy Director Cardiac Anesthesia, Dept. of Anesthesiology and Intensive Care Medicine

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 24, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

DE(1)