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

Sponsor

Sanatorio de la Trinidad Mitre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04209270

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

37 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Spontaneous breathing Trial [During 60 minutes after inclusion or until the patient fails to breathe spontaneously]
Period of time in which the patient breathes spontaneously

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanatorio de la Trinidad Mitre	Buenos Aires		Argentina

Sponsors and Collaborators

Sanatorio de la Trinidad Mitre

Investigators

Principal Investigator: Sebastian Fredes, RT, Sanatorio de la Trinidad Mitre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

María Lucía Gimenez, RT, Sanatorio de la Trinidad Mitre, Sanatorio de la Trinidad Mitre

ClinicalTrials.gov Identifier:

NCT04209270

Other Study ID Numbers:

WOB in ARDS

First Posted:

Dec 24, 2019

Last Update Posted:

Dec 26, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Aspiration

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of Dec 26, 2019