Ultrasound of the Diaphragm in ICU Patients

Completed

• Conditions: Critically Ill
• Interventions: Other: diaphragm ultrasound

• Registration Number: NCT01952262
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.

Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
• adults aortic vascular surgery

Exclusion Criteria

• < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
critically ill ICU patients	diaphragm ultrasound	critically ill intensive care unit patients

Primary Outcome Measures

Name	Time	Method
Diaphragmatic dysfunction	participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks	Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm

Trial Locations

Locations (1)

Ospedale San Raffaele di Milano; 🇮🇹 Milano, Italy