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

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.

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Key information

Conditions

Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brugmann hospital

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PVI and deltaPP after trendelenburg position change

Device

Comparison of hemodynamic parameters during surgery after position change

Primary outcomes

Pleth variability index (in %)

Time frame: 5 minutes

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

Time frame: 5 minutes

Before/after trendelenburg positioning in laparoscopic surgery

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
First posted: Mar 16, 2016
Registry last updated: Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed