Diaphragmatic Echography in Critically Ill patientS

Respiratory Failure Clinical Trial

— DECIS  

Official title:

Evaluation of Diaphragmatic Displacement During Spontaneous Breathing Trials in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696018
• Other study ID #: 138-2012
• Status: Completed
• Phase: N/A
• First received: February 13, 2016
• Last updated: February 25, 2016
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Ultrasonography
Ultrasonographic assessment of the diaphragm function

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (3)

DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23. — View Citation

Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. — View Citation

Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning success	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.	within the first 48 hours after the spontaneous breathing trial	No