Clinical trial NCT02696018: Diaphragmatic Echography in Critically Ill patientS
Official title: Evaluation of Diaphragmatic Displacement During Spontaneous Breathing Trials in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: Diaphragm
Ultrasound
Critically ill patients
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients undergoing a spontaneous breathing trial

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).


Eligibility criteria: 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

Primary outcomes:
measure: Weaning success
timeFrame: within the first 48 hours after the spontaneous breathing trial
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
References:
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. doi: 10.1378/chest.126.1.179.
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.
citation: 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.
citation: 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.