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

Intensive Care Patients Clinical Trial

— PVP-StepPEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05026255
• Other study ID #: 2020-A02683-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: August 2022

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Laurent GERGELE, MD
• Phone: 04 77 42 27 00
• Email: laurentgergele[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Patients

Intervention

Procedure:
• alveolar 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.

Locations

Country	Name	City	State
France	Hôpital Privé de la Loire	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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