Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling

NCT ID: NCT04899323

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2023-05-01

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.

Conditions

Sepsis With Hemodynamic Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

Perform a 250cc vascular filling over 10 minutes and then perform a cardiac ultrasound. Repeat the vascular filling followed by the ultrasound as long as the patient is responsive.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age> 18 years
• Patient with suspected infectious syndrome
• qSOFA >= 2
• Tachycardia>120 and/or PAS < 100mm Hg / MAP <60 mmHg

Exclusion Criteria

• Atrial fibrillation arrhythmia
• Vascular filling > 500 ml before hemodynamic evaluation by echo cardiography
• Perfusion of catecholamine (norepinephrine, epinephrine, or dobutamine) at the time of inclusion in the study (before hemodynamic assessment by echo cardiography)
• Patient sedated and on positive pressure ventilation, including NIV
• Tamponade due to a compressive pericardial or pleural effusion
• Patient with known pre-capillary PAH > 50 mmHg PAPS
• Presence of suspected acute valvulopathy requiring immediate cardiological expertise
• Absence of an acoustic window allowing the evaluation of the aortic or pulmonary ITV
• Minor patients, adults under guardianship, protected persons

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, Loire-Atlantique, France

Countries

France

Other Identifiers

RC21_0026

Identifier Type: -

Identifier Source: org_study_id