Subclavian Vein Diameter Variations to Assess Vascular Filling

NCT04946643 | Completed

• 2 other identifiers: APHP2105132021-A00694-37
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Haemodynamic optimisation is a fundamental step and a daily issue in the management of intensive care patients with acute circulatory failure. Failure to optimise haemodynamics is recognised as a factor associated with morbidity and mortality. Although the first line of treatment is often vascular filling, many studies have found that excessive vascular filling alone is deleterious and leads to increased morbidity and mortality due to pulmonary and interstitial oedema. The use of catecholamines avoids this undue vascular filling. At present, the therapeutic strategy in acute circulatory failure is to perform a personalised "titrated" vascular filling after assessing the need for it. To do this, predictive criteria for the need to continue vascular filling in order to optimise cardiac output and tissue perfusion pressure, particularly by ultrasound, have been developed, notably by transesophageal approach. It also appeared to us that offering an alternative to the transesophageal approach would reduce invasiveness on the one hand, but would also offer an alternative when the transesophageal approach is contraindicated.

Conditions

Acute Circulatory Failure

Keywords

acute circulatory failure; intensive care unit; echocardiography; superior and inferior vena cava

Outcome Measures

Primary Outcomes (1)

• Respiratory variations of subclavian vein diameter

  Correlation between respiratory variations in subclavian vein (SCV) diameter with cardiac output assessed by measuring respiratory variations in the subaortic velocity time integral

  at 5 minutes

Secondary Outcomes (1)

• Collapsibility index of the superior vena cava

  at 5 minutes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age over 18 years, Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation, affiliation with a social security scheme or entitled to it, information and non-objection of the patient to participate in the research.

You may qualify if:

• Age over 18 years;
• Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation;
• Affiliation with a social security scheme or entitled to it;
• Information and non-objection of the patient to participate in the research.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive care unit, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Romain Jouffroy, MD, PhD

  Intensive care unit, Ambroise Paré hospital, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 1, 2021
• Study Start: July 27, 2021
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)