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

NCT ID: NCT02709252

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort

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

Group Type EXPERIMENTAL

PVI and deltaPP after trendelenburg position change

Intervention Type DEVICE

Comparison of hemodynamic parameters during surgery after position change

Interventions

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PVI and deltaPP after trendelenburg position change

Comparison of hemodynamic parameters during surgery after position change

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Forget Patrice

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brugmann hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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201134

Identifier Type: -

Identifier Source: org_study_id

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