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
About this trial
This is an interventional diagnostic trial for Surgery
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).
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
NCT ID
NCT02709252
First Posted
March 3, 2016
Last Updated
March 10, 2016
Sponsor
Brugmann University Hospital
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
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Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
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