Clinical trial NCT04899323: Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling
Official title: Compares Changes in Pulmonary ITV Secondary to Vascular Filling to Reference Values Represented by Changes in Subaortic ITV in the Management of Sepsis in the Emergency Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis With Hemodynamic Instability
Keywords: Aortic ITV
Pulmonary ITV
Cardiac ultrasound
Hemodynamic ultrasound
Vascular filling
Sepsis
Emergency medicine
Recommendations
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients with sepsis requiring vascular filling

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.


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

Primary outcomes:
measure: Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV.
timeFrame: 5 months
Secondary outcomes:
measure: Investigate whether pulmonary ITV is more feasible than aortic ITV.
timeFrame: 5 months
measure: 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)
timeFrame: 5 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: