Diaphragmatic and Pulmonary US for Extu… | Clinical Trial

Key information

Conditions

Airway Extubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UANL University Hospital

Monterrey, Nuevo León, 64000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Thoracic ultrasound

Device

The ultrasound will be performed using the ultrasound system GE Logiq XP equipped with a linear probe of 10 MHz. The diaphragm is visualized as two parallel echogenic lines at the eighth intercostal space in the mid-axillary line. The images will be captured during the inspiratory and expiratory tidal volume to and during maximum inspiration and expiration. Each image will be frozen in B mode and the diaphragm thickness will be measured from the center line pleural half the peritoneal line. The fraction of diaphragmatic thickening it is calculated by the formula: diaphragmatic thickness at the end of inspiration - thickness to diaphragmatic at the end of exhalation / diaphragmatic thickness at the end of exhalation x 100. The number of areas with lines B also will be measured.

Primary outcomes

Extubation success

Time frame: 72 h after extubation

The investigators consider successful extubation when the patient does not require reintubation within 72 hours of its extubation

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Diaphragmatic Shortening Fraction and Pulmonary Ultrasound Combined Analysis for Extubation Success Prediction in Critical Care Patients

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 14, 2016
Registry last updated: Dec 14, 2018

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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Completed