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Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678559
Acronym
PreDeARM
Enrollment
24
Registered
2016-02-10
Start date
2016-02-29
Completion date
2016-12-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Coronary Artery Bypass, Coronary Artery Disease, Hypovolemia, Pulmonary Atelectasis

Keywords

Alveolar recruitment manoeuvre, Lung recruitment, Preload dependency, Cardiac surgery, Transoesophageal echocardiography

Brief summary

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

Detailed description

Population studied: anesthetized patients for cardiac surgery of coronary bypass. Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience) \- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation

Interventions

OTHERtee measurement
OTHERflotrac measurement
OTHERclearsight measurement

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected

Exclusion criteria

* Emergency case * Pericardial effusion * Aortic or mitral valvulopathy * Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion * Bad echogenicity * Patient refusal to participate to the study * No health insurance

Design outcomes

Primary

MeasureTime frameDescription
Variation of stroke volumeat the beginning of cardiac surgeryVariation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery

Secondary

MeasureTime frameDescription
Cardiac index (l/min/m2)at the begining of cardiac surgeryCardiac index (l/min/m2) (TEE measurement)
Right ventricle diameter/left ventricle diameter ratioat the begining of cardiac surgeryRight ventricle diameter/left ventricle diameter ratio (TEE measurement),
E/A ratioat the begining of cardiac surgeryE/A ratio (TEE measurement)
Sus-hepatic vein Doppler profileat the begining of cardiac surgerySus-hepatic vein Doppler profile (TEE measurement)
Invasive arterial pressure (mmHg)at the begining of cardiac surgery
Heart rate (pulse/min)at the begining of cardiac surgery
Expired CO2 (mmHg)at the begining of cardiac surgery
Central venous pressure (mmHg)at the begining of cardiac surgery
Pulse pressure variation (%)at the begining of cardiac surgery
Perfusion index (pulsoxymeter)at the begining of cardiac surgery
Velocity time integral (cm)at the begining of cardiac surgeryVelocity time integral (cm) (TEE measurement)
Stroke volume variation (%) (Flotrac measurement)at the begining of cardiac surgery
Cardiac index (l/min/m2) (Flotrac measurement)at the begining of cardiac surgery
Pulse pressure variation (%) (Flotrac measurement)at the begining of cardiac surgery
Arterial pressure (mmHg) (Flotrac measurement)at the begining of cardiac surgery
Stroke volume (ml) (Clearsight measurement)at the begining of cardiac surgery
Stroke volume variation (%) (Clearsight measurement)at the begining of cardiac surgery
Cardiac index (l/min/m2) (Clearsight measurement)at the begining of cardiac surgery
Pulse pressure variation (%) (Clearsight measurement)at the begining of cardiac surgery
Arterial pressure (mmHg) (Clearsight measurement)at the begining of cardiac surgery
Near infrared spectroscopy : Cerebral SrO2at the begining of cardiac surgery
Stroke volume (ml) (Flotrac measurement)at the begining of cardiac surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026