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

Not Applicable

Terminated

• Conditions: Intensive Care Patients
• Interventions: Procedure: alveolar recruitment manoeuvre by pressure step

• Registration Number: NCT05026255
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2021-12-08
• Primary Completion: 2022-08-29
• Study Completion: 2022-08-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mechanically ventilated intensive care patients.	alveolar recruitment manoeuvre by pressure step	Observational data collected for patients in intensive care under mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Primary outcome measure	through study completion, an average of 12 hours	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).

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure	through study completion, an average of 12 hours	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).

Trial Locations

Locations (1)

Hôpital Privé de la Loire; 🇫🇷 Saint-Étienne, France