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CompletedNCT03289975ODRUpdated Feb 6, 2026

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

An observational study in Digestive Surgery and Urinary Surgery, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
165
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Digestive Surgery
  • Urinary Surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chest surgery
  • ASA (American Society of Anesthesiologists) 4 or more
  • Refusal of the patient
  • Pregnant women
  • Spontaneously-breathing patients
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
165 participants (actual)
Patient registry
No

Interventions

  • Otherpulmonary ultrasound

    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).

05

What researchers measure

Primary outcomes

  1. Onset of post-operative acute respiratory distress

    Time frame: 28 days

06

Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, France
07

References and documents

Publications

  • 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. PubMed 31549404 ↗
08

Registry details

Key details

Study ID
NCT03289975
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Mar 12, 2016
Primary completion
Mar 29, 2017
Completion
Mar 29, 2017
Last update
Feb 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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