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Completed

NCT Number: NCT02696018

Diaphragmatic Echography in Critically Ill patientS

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).

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography

Device

Ultrasonographic assessment of the diaphragm function

Primary outcomes

  1. Weaning success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Acronym: DECIS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2016
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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