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Clinical Trials/NCT02732041
NCT02732041
Completed
N/A

Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno5 sites in 1 country103 target enrollmentMay 25, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Adult
Sponsor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Enrollment
103
Locations
5
Primary Endpoint
Asynchrony rate
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. The purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

Detailed Description

Major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. Few studies have evaluated double cycling in ARDS patient. No clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. This study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. A blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. Clinical and outcome data will be recorded.

Registry
clinicaltrials.gov
Start Date
May 25, 2016
End Date
February 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Responsible Party
Principal Investigator
Principal Investigator

Pablo Oscar Rodriguez

Assosiated Professor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Eligibility Criteria

Inclusion Criteria

  • Acute Respiratory Distress Syndrome according to Berlin definition
  • Intubation and mechanical ventilation within 72 hours of inclusion

Exclusion Criteria

  • Known severe neuromuscular disease
  • Continuous neuromuscular blocking agents infusion

Outcomes

Primary Outcomes

Asynchrony rate

Time Frame: 30 minutes

Asynchronies per minutes of mechanical ventilation

Secondary Outcomes

  • ICU mortality(From the date of admission to the date of discharge from the ICU, up to 90 days)
  • Hospital mortality(From the date of admission to the date of discharge from the ICU, up to 90 days)
  • Length of mechanical ventilation(From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days)

Study Sites (5)

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