Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre

Study Overview
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Brief Summary
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Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre. Prospective multicentre open-label study of mechanically ventilated intensive care patients.

Official Title
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Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre

Conditions
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Intensive Care Patients

Intervention / Treatment
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* Procedure: alveolar recruitment manoeuvre by pressure step


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation Equipped with a central venous line in the superior vena cava territory and an arterial catheter. Whose state of health justifies vascular filling Exclusion Criteria: Patient under legal protection, guardianship or curatorship Pregnant or breastfeeding woman Patient not affiliated to the French social security system Contraindication to the realization of an alveolar recruitment maneuver

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective multicentre open-label study of mechanically ventilated intensive care patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mechanically ventilated intensive care patients.<br>Observational data collected for patients in intensive care under mechanical ventilation. | Procedure: alveolar recruitment manoeuvre by pressure step<br>* The application of alveolar recruitment manoeuvres consists of transiently increasing alveolar pressure in order to re-open collapsed alveolar territories and to re-ventilate poorly ventilated or non-ventilated lung areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure | The correlation between the pairs of values of CVP and PVP during an alveolar recruitment manoeuvre will be evaluated by Pearson's coefficient or Spearman's coefficient if the distribution of the values is not parametric. The coefficient of determination r² will be calculated by linear regression between the 2 variables. Finally, the agreement between the two measurements will be evaluated by the Bland-Altman method: the Bland-Altman graph will be provided and the 95% agreement limits will be calculated (+/- 1.96 SD, SD being the standard deviation of the difference between the measurements). | through study completion, an average of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measure | Predictive value of the evolution of PVP during the recruitment manoeuvre: the ROC curve (receiver-operating characteristic) will be performed by logistic regression. The area under the ROC curve will be given as well as the sensitivity, specificity and negative and positive predictive values (Younden index will be used to determine the optimal threshold of PVP). | through study completion, an average of 12 hours |