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

Digestive Surgery Clinical Trial

— ODR  

Official title:

Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289975
• Other study ID #: DRANSART BOUHEMAD 2016
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: September 19, 2017
• Start date: March 12, 2016
• Est. completion date: March 29, 2017

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive Surgery
• Urinary Surgery

Intervention

Other:
• pulmonary 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).

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of post-operative acute respiratory distress		28 days