Diaphragmatic and Pulmonary US for Extubation Success Prediction

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Completed
CT.gov ID
NCT02799056
Collaborator
(none)
82
1
13
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Thoracic ultrasound

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 Design

Study Type:
Observational
Actual Enrollment :
82 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Diaphragmatic Shortening Fraction and Pulmonary Ultrasound Combined Analysis for Extubation Success Prediction in Critical Care Patients
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Extubation success [72 h after extubation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UANL University Hospital Monterrey Nuevo León Mexico 64000

Sponsors and Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Study Director: Julio E González, MD, Universidad Autónoma de Nuevo León

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Julio Edgardo González Aguirre, Dr., Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT02799056
Other Study ID Numbers:
  • NM16-00003
First Posted:
Jun 14, 2016
Last Update Posted:
Dec 14, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Julio Edgardo González Aguirre, Dr., Hospital Universitario Dr. Jose E. Gonzalez

Study Results

No Results Posted as of Dec 14, 2018