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Clinical Trials/NCT07205952
NCT07205952RecruitingNot Applicable

Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

Hospital de Clinicas José de San Martín1 site in 1 country60 target enrollmentStarted: November 22, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.

Study Overview

Brief Summary

The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.

Detailed Description

Inclusion criteria:

  • Adults of either sex (≥18 years)
  • Non-c0mmunicative, endotracheally intubated in the past 24 hours.
  • Expected to require ≥24 hours of mechanical ventilation.

Exclusion criteria:

  • Continuous neuromuscular blockade.
  • Ventilated on Airway Pressure Release Ventilation mode.

Ventilator measured airway pressure and flow signals will be streamed at 31.25 Hz into 131.1-s time windows (epochs) for up to 5 days. A recursive algorithm will compute individual breath's inspiratory effort (Pmus) and calculate the inspiratory effort time-pressure product (PmusPTP cmH₂O·s·min-¹).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.

Time Frame: One year

The degree of correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score will be determined with Pearson's coefficient of determination (R2).

Secondary Outcomes

  • Ventilator free days.(One year)

Investigators

Sponsor
Hospital de Clinicas José de San Martín
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Celica Irrazabal

Director, Intensive Care Unit and Co-Principal Investigator

Hospital de Clinicas José de San Martín

Study Sites (1)

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