Ultrasound of the Diaphragm in ICU Patients

NCT01952262 | Completed

• 1 other identifier: OSR/39/05/13
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

ultrasound; diaphragm; intensive care; critical care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

critically ill ICU patients

critically ill intensive care unit patients

Other: diaphragm ultrasound

Interventions

diaphragm ultrasound OTHER

we'll perform diaphragm ultrasound in ICU critically ill patients

Also known as: echography of diaphragm

critically ill ICU patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients

You may qualify if:

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

You may not qualify if:

• \< 18 years

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele di Milano

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Zambon, MD

  San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: September 27, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

IT (1)