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Breathing Pattern, WOB and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04209270
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : December 26, 2019
Information provided by (Responsible Party):
María Lucía Gimenez, Sanatorio de la Trinidad Mitre

Brief Summary:
There is little evidence about the mechanical characteristics and muscular function in patients with Acute Respiratory Distress Syndrome (ARDS) at the time of weaning of the mechanical ventilation, as well as the behavior of the mechanical properties, breathing pattern, muscular effort, and gas exchange during a successful and failed spontaneous breathing trial.

Condition or disease
Work of Breathing ARDS Weaning Failure

Detailed Description:

The study of the respiratory system (RS) mechanics in patients with ARDS has been focused on the initial phase of ventilatory support, with few studies observing the weaning in mechanical ventilation.The RS in patients with ARDS is characterized by a greater or lesser degree of low functional residual capacity (FRC) in relation to normal.

At the time of performing a spontaneous breathing trial, these mechanical characteristics determine the need to develop a high transpulmonary pressure during each breath, with high work of breathing (WOB) to achieve adequate alveolar ventilation.

Inspiratory muscle weakness could alter the ability to generate the necessary transpulmonary pressure over time according to the loads imposed at the time of performing a spontaneous breathing trial, with the consequent development of fatigue and ventilatory failure.

This is why the investigators propose to evaluate the association between elastic WOB and the failure of the spontaneous breathing trial.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Breathing Pattern, Work of Breathing and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Primary Outcome Measures :
  1. Spontaneous breathing Trial [ Time Frame: During 60 minutes after inclusion or until the patient fails to breathe spontaneously ]
    Period of time in which the patient breathes spontaneously

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will meassure adult, ARDS, Intensive Care Unit patients that are able to perform a Spontaneous Breathing Trial.

Inclusion Criteria:

  • over 18 years old
  • requiring mechanical ventilation for more than 12 hours
  • moderate/ severe ARDS according to Berlin Definition
  • able to make a Spontaneous Breathing Trial according to the institution protocol

Exclusion Criteria:

  • pregnant patients
  • history of neuromuscular disease
  • patients in palliative care
  • bronchopleural fistula
  • contraindication of measurement of esophageal pressure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04209270

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Contact: Emilio Steinberg, RT 0054 91164977663
Contact: Sebastian Fredes, RT

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Sanatorio de la Trinidad Mitre Recruiting
Buenos Aires, Argentina
Contact: Emilio Steinberg, RT   
Contact: Sebastian Fredes, RT   
Sponsors and Collaborators
Sanatorio de la Trinidad Mitre
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Principal Investigator: Sebastian Fredes, RT Sanatorio de la Trinidad Mitre
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Responsible Party: María Lucía Gimenez, RT, Sanatorio de la Trinidad Mitre, Sanatorio de la Trinidad Mitre Identifier: NCT04209270    
Other Study ID Numbers: WOB in ARDS
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury