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Clinical Trials/NCT05026255
NCT05026255
Terminated
Not Applicable

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

GCS Ramsay Santé pour l'Enseignement et la Recherche1 site in 1 country21 target enrollmentDecember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Patients
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment
21
Locations
1
Primary Endpoint
Primary outcome measure
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 8, 2021
End Date
August 29, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Primary outcome measure

Time Frame: 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 Outcomes

  • Secondary outcome measure(through study completion, an average of 12 hours)

Study Sites (1)

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