Work of BreathingNCT04209270
Breathing Pattern, WOB and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
An observational study of Work of Breathing and ARDS, run by Sanatorio de la Trinidad Mitre at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Work of Breathing, ARDS, Weaning Failure
- How many people
- 37 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Apr 2019to 1 Dec 2022
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will meassure adult, ARDS, Intensive Care Unit patients that are able to perform a Spontaneous Breathing Trial.
Who may be able to join
- 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
Who cannot join
- pregnant patients
- history of neuromuscular disease
- patients in palliative care
- bronchopleural fistula
- contraindication of measurement of esophageal pressure
Trial locations and contacts
1 site in 1 country.
Sebastian Fredes, RT contact
Argentina1 site, 1 recruiting
- Recruiting
Sanatorio de la Trinidad Mitre
Buenos Aires
Emilio Steinberg, RT, emi.steinberg@gmail.com
Sebastian Fredes, RT, sebastian_fredes@hotmail.com
About this study
Official title: Breathing Pattern, Work of Breathing and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
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.
Read the 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.
- Conditions
- Work of Breathing, ARDS, Weaning Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous breathing Trial
Period of time in which the patient breathes spontaneously
Measured: During 60 minutes after inclusion or until the patient fails to breathe spontaneously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work of BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Sanatorio de la Trinidad Mitre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Lucía Gimenez, Sanatorio de la Trinidad Mitre
- Investigators
- Sebastian Fredes, RT, Principal investigator, Sanatorio de la Trinidad Mitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209270
- Sponsor's protocol ID
- WOB in ARDS
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Pattern, Work of Breathing and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
- ClinicalTrials.gov ID
- NCT04209270
- Acronym / sponsor ID
- WOB in ARDS
- Conditions
- Work of Breathing, ARDS, Weaning Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sanatorio de la Trinidad MitreUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will meassure adult, ARDS, Intensive Care Unit patients that are able to perform a Spontaneous Breathing Trial.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- pregnant patients
- history of neuromuscular disease
- patients in palliative care
- bronchopleural fistula
- contraindication of measurement of esophageal pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Fredes, RT contact
Sebastian Fredes, RT principal investigator
Sanatorio de la Trinidad Mitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work of Breathing and ARDS, run by Sanatorio de la Trinidad Mitre at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilio Steinberg, RT (0054 91164977663, emi.stieinberg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous breathing Trial (time frame: During 60 minutes after inclusion or until the patient fails to breathe spontaneously). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.