Diaphragmatic and Pulmonary US for Extubation Success Prediction

December 12, 2018 updated by: Julio Edgardo González Aguirre, Hospital Universitario Dr. Jose E. Gonzalez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • UANL University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 h after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Study Director: Julio E González, MD, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (ESTIMATE)

June 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NM16-00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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