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

NCT03289975 | Completed

• 1 other identifier: DRANSART BOUHEMAD 2016
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Surgery; Urinary Surgery

Outcome Measures

Primary Outcomes (1)

• Onset of post-operative acute respiratory distress

  28 days

Interventions

pulmonary ultrasound OTHER

Collect the aeration profile for each lung quadrant: profile A, profile B1, profile B2, profile C. Calculate the aeration score from O to 36 (LUS (Lung ultrasound) score).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing digestive or urinary surgery and requiring post-operative intensive care

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, France

Location

Related Publications (1)

• Dransart-Raye O, Roldi E, Zieleskiewicz L, Guinot PG, Mojoli F, Mongodi S, Bouhemad B. Lung ultrasound for early diagnosis of postoperative need for ventilatory support: a prospective observational study. Anaesthesia. 2020 Feb;75(2):202-209. doi: 10.1111/anae.14859. Epub 2019 Sep 23.

  PMID: 31549404 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: March 12, 2016
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)