Clinical trial NCT02799056: Diaphragmatic and Pulmonary US for Extubation Success Prediction
Official title: Diaphragmatic Shortening Fraction and Pulmonary Ultrasound Combined Analysis for Extubation Success Prediction in Critical Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Extubation
Keywords: Airway Extubation
Ultrasonography
Ventilator Weaning
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years or older patients, hospitalized in medical or surgical intensive care unit of the University Hospital "Dr. José E. González "from 1 may 2016 until the sample size is completed and who have successful spontaneous ventilation trial as part of routinely applied extubation protocol.

Brief summary: The primary objective is to assess whether the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit.

Detailed description: The primary objective is to assess whether the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit. The investigators' null hypothesis is the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound can not predict the success of extubation in adult patients hospitalized in the intensive care unit.

The alternative hypothesis is the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit.

The study is a no experimental study of diagnostic test, prospective with longitudinal capture. The study will consist of two parts: the first with the aim of finding the values best combination of sensitivity and specificity compared to extubation success for diaphragmatic shortening fraction and the number of lung quadrants with lines B. In the second part the study will make the prospective validation of these values.

Eligibility criteria: Inclusion Criteria:

* 18 years of older
* Hospitalized in medical or surgical intensive care unit
* Successful spontaneous ventilation trial

Exclusion Criteria:

* Patients reintubated after a first failure after extubation
* Injuries to prevent conduct ultrasound
* Pregnancy
* History of neuromuscular disease
* Brain injury that prevented adequate protection of the airway (Glasgow Coma Scale \<8)
* Unilateral or bilateral Pneumothorax
* Presence of chest tube in right hemothorax
* Right subphrenic abscess
* Known uni- or bilateral phrenic nerve injury
* Unilateral or bilateral diaphragmatic Paralysis
* Unwillingness of the patient or guardian to participate in the study

Primary outcomes:
measure: Extubation success
timeFrame: 72 h after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: UANL University Hospital
state: Nuevo León
Study officials:
affiliation: Universidad Autónoma de Nuevo León
name: Julio E González, MD
role: STUDY_DIRECTOR
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