Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling

Completed

• Conditions: Sepsis With Hemodynamic Instability

• Registration Number: NCT04899323
• Lead Sponsor: Nantes University Hospital

Brief Summary

This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.

For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.

This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.

The evolution of ITV measurements and vital parameters should be recorded for each patient.

In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.

At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-07-21
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV.	5 months	Aortic ITV and pulmonary ITV

Secondary Outcome Measures

Name	Time	Method
Investigate whether pulmonary ITV is more feasible than aortic ITV.	5 months	Proportion of cases where Aortic ITV measurement is not feasible as opposed to pulmonary ITV.
Exploratory search for an indicator threshold for pulmonary ITV corresponding to the 10% threshold of aortic ITV (provided that pulmonary ITV and aortic ITV are correlated)	5 months	Pulmonary ITV and Aortic ITV

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France