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NCT01952262 Clinical Trial

Ultrasound of the Diaphragm in ICU Patients

Critically Ill Clinical Trial

Official title:
Ultrasound Evaluation of Diaphragmatic Dysfunction in Critically Ill Patients. An Observational Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01952262
Other study ID # OSR/39/05/13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date December 2022

Study information
Verified date December 2022
Source Università Vita-Salute San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• diaphragm ultrasound
we'll perform diaphragm ultrasound in ICU critically ill patients

Locations
Country Name City State
Italy Ospedale San Raffaele di Milano Milano

Sponsors (1)
Lead Sponsor Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diaphragmatic dysfunction Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks
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