Diaphragmatic Echography in Critically Ill patientS

Completed

• Conditions: Respiratory Failure
• Interventions: Device: Ultrasonography

• Registration Number: NCT02696018
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been introduced in the clinical practice to evaluate diaphragmatic function. In particular, the investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography. The aim of this study was to compare the diaphragmatic displacement with traditional weaning parameters in potentially ready to be extubated patients undergoing a spontaneous breathing trial (SBT).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-13
• Study First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Study First Posted: 2016-03-02
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• mechanically ventilated since more than 24 hours
• clinical improvement of the underlying acute cause of the respiratory failure
• adequate cough reflex
• absence of excessive and/or purulent tracheobronchial secretion
• stable cardiovascular status
• stable metabolic status
• adequate pulmonary function
• adequate mentation

Exclusion Criteria

• age <18 years
• pregnancy
• presence of thoracostomy, pneumothorax or pneumomediastinum
• presence of flail chest or rib fractures
• neuromuscular disease
• use of muscle-paralyzing agents within 48 hours before the study
• history or new detection of paralysis or paradoxical movement of a single hemi-diaphragm on diaphragm ultrasonography

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	Ultrasonography	Ultrasonography in critically ill patients in weaning from mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Weaning success	within the first 48 hours after the spontaneous breathing trial	A successful weaning attempt was registered when patients were extubated and breathed spontaneously for more than 48 hours. The reinstitution of mechanical ventilation at the end of spontaneous breathing trial, reintubation within 48 hours or non-invasive ventilation (NIV) support after extubation defined a failed weaning attempt.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy