NCT02709252

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 3, 2016

Last Update Submit

March 10, 2016

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

  • Pleth variability index (in %)

    Before/after trendelenburg positioning in laparoscopic surgery

    5 minutes

  • Pulse Pressure variation (deltaPP) (in %)

    Before/after trendelenburg positioning in laparoscopic surgery

    5 minutes

Study Arms (1)

Cohort

EXPERIMENTAL

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

Device: PVI and deltaPP after trendelenburg position change

Interventions

PVI and deltaPP after trendelenburg position changeDEVICE

Comparison of hemodynamic parameters during surgery after position change

Cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brugmann hospital

Brussels, Belgium

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 16, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

BE(1)