Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— PreMiTE-ARDS  

Official title:

Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763773
• Other study ID #: 2017_30
• Secondary ID: 2018-A01463-52
• Status: Completed
• Start date: April 21, 2019
• Est. completion date: April 20, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital.

• With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours.

• Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode.

• Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient).

Exclusion Criteria:

• Patient under extracorporeal respiratory assistance at the time of inclusion.

• Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe:

• Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach

• History of esophageal and / or gastric surgery

• Caustic lesions of the esophagus and / stomach

• Tumor or history of oropharyngeal surgery

• Unstable lesions of the cervical spine

• Coagulopathy (thrombocytopenia <50 109 / L and / or TP <50%).

• Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity.

• Pregnant woman.

• Therapeutic limitation measures limiting the treatment of organ failure.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days lived without mechanical ventilation	This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days.	at 28 days
Secondary	number of patient of death		At 28 days, at 90 days