---
title: Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
nct_id: NCT02678559
overall_status: COMPLETED
phase: NA
sponsor: University Hospital, Clermont-Ferrand
study_type: INTERVENTIONAL
primary_condition: Coronary Artery Disease
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02678559.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02678559"
ct_last_update_post_date: 2017-04-20
last_seen_at: "2026-05-12T06:12:12.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

**NCT ID:** [NCT02678559](https://clinicaltrials.gov/study/NCT02678559)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** University Hospital, Clermont-Ferrand
- **Conditions:** Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia, Anesthesia, General, Pulmonary Atelectasis
- **Start Date:** 2016-02
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2017-04-20

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **TEE monitory system** (EXPERIMENTAL) — comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
- **mini-invasive monitoring system** (EXPERIMENTAL) — comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

## Interventions

- **tee measurement** (OTHER)
- **flotrac measurement** (OTHER)
- **clearsight measurement** (OTHER)

## Primary Outcomes

- **Variation of stroke volume** _(time frame: at the beginning of cardiac surgery)_ — Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery

## Secondary Outcomes

- **Velocity time integral (cm)** _(time frame: at the begining of cardiac surgery)_
- **Velocity time integral (cm)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Velocity time integral (cm)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Cardiac index (l/min/m2)** _(time frame: at the begining of cardiac surgery)_
- **Cardiac index (l/min/m2)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Cardiac index (l/min/m2)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Right ventricle diameter/left ventricle diameter ratio** _(time frame: at the begining of cardiac surgery)_
- **Right ventricle diameter/left ventricle diameter ratio** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Right ventricle diameter/left ventricle diameter ratio** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **E/A ratio** _(time frame: at the begining of cardiac surgery)_
- **E/A ratio** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **E/A ratio** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Sus-hepatic vein Doppler profile** _(time frame: at the begining of cardiac surgery)_
- **Sus-hepatic vein Doppler profile** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Sus-hepatic vein Doppler profile** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Invasive arterial pressure (mmHg)** _(time frame: at the begining of cardiac surgery)_
- **Invasive arterial pressure (mmHg)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Invasive arterial pressure (mmHg)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Heart rate (pulse/min)** _(time frame: at the begining of cardiac surgery)_
- **Heart rate (pulse/min)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Heart rate (pulse/min)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Expired CO2 (mmHg)** _(time frame: at the begining of cardiac surgery)_
- **Expired CO2 (mmHg)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Expired CO2 (mmHg)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Central venous pressure (mmHg)** _(time frame: at the begining of cardiac surgery)_
- **Central venous pressure (mmHg)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Central venous pressure (mmHg)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Pulse pressure variation (%)** _(time frame: at the begining of cardiac surgery)_
- **Pulse pressure variation (%)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Pulse pressure variation (%)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Perfusion index (pulsoxymeter)** _(time frame: at the begining of cardiac surgery)_
- **Perfusion index (pulsoxymeter)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Perfusion index (pulsoxymeter)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Stroke volume (ml) (Flotrac measurement)** _(time frame: at the begining of cardiac surgery)_
- **Stroke volume (ml) (Flotrac measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Stroke volume (ml) (Flotrac measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Stroke volume variation (%) (Flotrac measurement)** _(time frame: at the begining of cardiac surgery)_
- **Stroke volume variation (%) (Flotrac measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Stroke volume variation (%) (Flotrac measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Cardiac index (l/min/m2) (Flotrac measurement)** _(time frame: at the begining of cardiac surgery)_
- **Cardiac index (l/min/m2) (Flotrac measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Cardiac index (l/min/m2) (Flotrac measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Pulse pressure variation (%) (Flotrac measurement)** _(time frame: at the begining of cardiac surgery)_
- **Pulse pressure variation (%) (Flotrac measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Pulse pressure variation (%) (Flotrac measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Arterial pressure (mmHg) (Flotrac measurement)** _(time frame: at the begining of cardiac surgery)_
- **Arterial pressure (mmHg) (Flotrac measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Arterial pressure (mmHg) (Flotrac measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Stroke volume (ml) (Clearsight measurement)** _(time frame: at the begining of cardiac surgery)_
- **Stroke volume (ml) (Clearsight measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Stroke volume (ml) (Clearsight measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Stroke volume variation (%) (Clearsight measurement)** _(time frame: at the begining of cardiac surgery)_
- **Stroke volume variation (%) (Clearsight measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Stroke volume variation (%) (Clearsight measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Cardiac index (l/min/m2) (Clearsight measurement)** _(time frame: at the begining of cardiac surgery)_
- **Cardiac index (l/min/m2) (Clearsight measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Cardiac index (l/min/m2) (Clearsight measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Pulse pressure variation (%) (Clearsight measurement)** _(time frame: at the begining of cardiac surgery)_
- **Pulse pressure variation (%) (Clearsight measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Pulse pressure variation (%) (Clearsight measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Arterial pressure (mmHg) (Clearsight measurement)** _(time frame: at the begining of cardiac surgery)_
- **Arterial pressure (mmHg) (Clearsight measurement)** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Arterial pressure (mmHg) (Clearsight measurement)** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_
- **Near infrared spectroscopy : Cerebral SrO2** _(time frame: at the begining of cardiac surgery)_
- **Near infrared spectroscopy : Cerebral SrO2** _(time frame: After fluid challenges until patient is on a preload independency state.)_
- **Near infrared spectroscopy : Cerebral SrO2** _(time frame: After the cardiopulmonary bypass period, when sternotomy will be closed)_

## Locations (1)

- CHU Clermont-Ferrand, Clermont-Ferrand, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu clermont-ferrand|clermont-ferrand||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02678559.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02678559*  
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