Diaphragmatic Echography in Critically Ill patientS

NCT ID: NCT02696018

Last Updated: 2016-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill patients

Ultrasonography in critically ill patients in weaning from mechanical ventilation

Ultrasonography

Intervention Type DEVICE

Ultrasonographic assessment of the diaphragm function

Interventions

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Ultrasonography

Ultrasonographic assessment of the diaphragm function

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 15249460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21705883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24365607 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27677861 (View on PubMed)

Other Identifiers

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138-2012

Identifier Type: -

Identifier Source: org_study_id

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