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

NCT05026255 | Terminated

• 1 other identifier: 2020-A02683-36
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome measure

  through study completion, an average of 12 hours

Study Arms (1)

mechanically ventilated intensive care patients.

EXPERIMENTAL

Observational data collected for patients in intensive care under mechanical ventilation.

Procedure: alveolar recruitment manoeuvre by pressure step

Interventions

alveolar recruitment manoeuvre by pressure step PROCEDURE

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.

mechanically ventilated intensive care patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé de la Loire

Saint-Etienne, 42100, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 30, 2021
• Study Start: December 8, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

FR (1)