Peripheral Venous Pressure Variation and Fluid Responsiveness

NCT05131516 | Completed

• 1 other identifier: IRBN902021/CHUSTE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders. Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• Ability of the peripheral venous pressure to predict fluid responsiveness

  we will induce, before skin incision, an alveolar recrutment maneuver (standard of care) and observe variations of peripheral venous pressure, then, it will be followed by a volume expansion of 4ml/kg over 5 minutes

  during surgery

Interventions

Alveolar recrutment maneuver DIAGNOSTIC_TEST

alveolar recruitment maneuver (30 mmHg for 30 seconds)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a high-risk abdominal surgery ( liver resection and pancreatectomy)

You may qualify if:

• Adult patients
• Patients scheduled for a high-risk abdominal surgery
• Patients equipped with an arterial line connected to an cardiac output hemodynamic monitoring device ( Flotrac, EV1000, Edwards Lifesciences, Irvine, USA)
• Patients in whom a recrutment maneuver is planned as per standard of care

You may not qualify if:

• Arythmia ( atrial fibrillation)
• Right ventricular dysfunction

Sponsors & Collaborators

• Erasme University Hospital: lead
• Université Paris-Saclay-Assistance publique des hôpitaux de Paris: collaborator

Study Sites (1)

ALEXANDRE joosten

Villejuif, 94800, France

Location

Study Officials

• ALEXANDRE JOOSTEN, MD PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 23, 2021
• Study Start: January 10, 2022
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)