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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05026255
Acronym
PVP-StepPEP
Enrollment
21
Registered
2021-08-30
Start date
2021-12-08
Completion date
2022-08-29
Last updated
2024-07-01

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

Conditions

Intensive Care Patients

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.

Interventions

PROCEDUREalveolar recruitment manoeuvre by pressure step

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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective multicentre open-label study of mechanically ventilated intensive care patients.

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome measurethrough study completion, an average of 12 hoursThe 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

MeasureTime frameDescription
Secondary outcome measurethrough study completion, an average of 12 hoursPredictive 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).

Countries

France

Outcome results

None listed

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