Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

January 2, 2020 updated by: Pablo Oscar Rodriguez, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, 1431
        • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
        • Complejo Medico Churruca Visca
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
        • Sanatorio Anchorena
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
        • Sanatorio La Trinidad Mitre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation for less than 72 hours

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asynchrony rate
Time Frame: 30 minutes
Asynchronies per minutes of mechanical ventilation
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of mechanical ventilation
Time Frame: From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days
From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days
ICU mortality
Time Frame: From the date of admission to the date of discharge from the ICU, up to 90 days
From the date of admission to the date of discharge from the ICU, up to 90 days
Hospital mortality
Time Frame: From the date of admission to the date of discharge from the ICU, up to 90 days
From the date of admission to the date of discharge from the ICU, up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Investigators

  • Principal Investigator: Pablo O Rodriguez, MD, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

November 22, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

March 19, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMIC1008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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