Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery

Completed

• Conditions: Digestive Surgery; Urinary Surgery

• Registration Number: NCT03289975
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema.

The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-12
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Status Verified: 2017-09
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Study First Posted: 2017-09-21
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

All patients undergoing scheduled or emergency visceral surgery and admitted to an ICU following the intervention.

Exclusion Criteria

• Chest surgery
• ASA (American Society of Anesthesiologists) 4 or more
• Refusal of the patient
• Pregnant women
• Spontaneously-breathing patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset of post-operative acute respiratory distress	28 days

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France