Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.

March 10, 2016 updated by: Forget Patrice, Brugmann University Hospital
Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

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

  • Belgium
      • Brussels, Belgium
        • Brugmann hospital

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • American Society of Anesthesiologists (ASA) score I-II
  • scheduled for elective abdominal laparoscopic surgery
  • with written informed consent
  • more than 18 years
  • Body Mass Index < 40 kg.m-2
  • no supraventricular arrhythmias
  • no heart failure with ejection fraction <25 %
  • no peripheral vascular
  • no severe respiratory disease
  • no end stage renal failure (creatinine clearance <30ml/min).

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: Cohort
Only one cohort is included with comparisons of two different hemodynamic parameters
Device: PVI and deltaPP after trendelenburg position change
Comparison of hemodynamic parameters during surgery after position change

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pleth variability index (in %)
Time Frame: 5 minutes
Before/after trendelenburg positioning in laparoscopic surgery
5 minutes
Pulse Pressure variation (deltaPP) (in %)
Time Frame: 5 minutes
Before/after trendelenburg positioning in laparoscopic surgery
5 minutes

Collaborators and Investigators

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

Sponsor

Brugmann University Hospital

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

January 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201134

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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