search
Back to results

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

Primary Purpose

Surgery

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
PVI and deltaPP after trendelenburg position change
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Surgery

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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).

Sites / Locations

  • Brugmann hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Only one cohort is included with comparisons of two different hemodynamic parameters

Outcomes

Primary Outcome Measures

Pleth variability index (in %)
Before/after trendelenburg positioning in laparoscopic surgery
Pulse Pressure variation (deltaPP) (in %)
Before/after trendelenburg positioning in laparoscopic surgery

Secondary Outcome Measures

Full Information

First Posted
March 3, 2016
Last Updated
March 10, 2016
Sponsor
Brugmann University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02709252
Brief Title
Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
Official Title
Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Arm Description
Only one cohort is included with comparisons of two different hemodynamic parameters
Intervention Type
Device
Intervention Name(s)
PVI and deltaPP after trendelenburg position change
Intervention Description
Comparison of hemodynamic parameters during surgery after position change
Primary Outcome Measure Information:
Title
Pleth variability index (in %)
Description
Before/after trendelenburg positioning in laparoscopic surgery
Time Frame
5 minutes
Title
Pulse Pressure variation (deltaPP) (in %)
Description
Before/after trendelenburg positioning in laparoscopic surgery
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Brugmann hospital
City
Brussels
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs