NCT04209270

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

3.7 years

First QC Date

December 19, 2019

Last Update Submit

December 23, 2019

Conditions

Work of BreathingARDSWeaning Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will meassure adult, ARDS, Intensive Care Unit patients that are able to perform a Spontaneous Breathing Trial.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

RECRUITING

Study Officials

  • Sebastian Fredes, RT

    Sanatorio de la Trinidad Mitre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Steinberg, RT

CONTACT

0054 91164977663emi.stieinberg@gmail.com

Sebastian Fredes, RT

CONTACT

sebastian_fredes@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RT, Sanatorio de la Trinidad Mitre

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 24, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

AR(1)