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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209270
• Other study ID #: WOB in ARDS
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2019
• Source: Sanatorio de la Trinidad Mitre
• Contact: Emilio Steinberg, RT
• Phone: 0054 91164977663
• Email: emi.stieinberg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Aspiration
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Weaning Failure
• Work of Breathing

Locations

Country	Name	City	State
Argentina	Sanatorio de la Trinidad Mitre	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sanatorio de la Trinidad Mitre

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous breathing Trial	Period of time in which the patient breathes spontaneously	During 60 minutes after inclusion or until the patient fails to breathe spontaneously