Skip to main content
OpenTrials
Completed

NCT Number: NCT04899323

Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV.

    Time frame: 5 months

    Aortic ITV and pulmonary ITV

Secondary outcomes

  1. Investigate whether pulmonary ITV is more feasible than aortic ITV.

    Time frame: 5 months

    Proportion of cases where Aortic ITV measurement is not feasible as opposed to pulmonary ITV.

  2. 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)

    Time frame: 5 months

    Pulmonary ITV and Aortic ITV

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: CIAOP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2021
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.