NCT02696018

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

February 13, 2016

Last Update Submit

February 25, 2016

Conditions

Respiratory Failure

Keywords

DiaphragmUltrasoundCritically ill patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Critically ill patients

Ultrasonography in critically ill patients in weaning from mechanical ventilation

Device: Ultrasonography

Interventions

UltrasonographyDEVICE

Ultrasonographic assessment of the diaphragm function

Critically ill patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients undergoing a spontaneous breathing trial

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Location

Related Publications (4)

  • 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. doi: 10.1378/chest.126.1.179.

    PMID: 15249460BACKGROUND

  • 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.

    PMID: 21705883BACKGROUND

  • 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.

    PMID: 24365607BACKGROUND

  • Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.

    PMID: 27677861DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 13, 2016

First Posted

March 2, 2016

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

IT(1)