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

Phase 2

Completed

• Conditions: Surgery
• Interventions: Device: PVI and deltaPP after trendelenburg position change

• Registration Number: NCT02709252
• Lead Sponsor: Brugmann University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Study First Posted: 2016-03-16
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	PVI and deltaPP after trendelenburg position change	Only one cohort is included with comparisons of two different hemodynamic parameters

Primary Outcome Measures

Name	Time	Method
Pulse Pressure variation (deltaPP) (in %)	5 minutes	Before/after trendelenburg positioning in laparoscopic surgery
Pleth variability index (in %)	5 minutes	Before/after trendelenburg positioning in laparoscopic surgery

Trial Locations

Locations (1)

Brugmann hospital; 🇧🇪 Brussels, Belgium