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Completed

NCT Number: NCT02732041

Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Medico Churruca Visca, Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Asynchrony rate

    Time frame: 30 minutes

    Asynchronies per minutes of mechanical ventilation

Secondary outcomes

  1. 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

  2. ICU mortality

    Time frame: From the date of admission to the date of discharge from the ICU, up to 90 days

  3. Hospital mortality

    Time frame: From the date of admission to the date of discharge from the ICU, up to 90 days

Sponsors and collaborators

Lead sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 8, 2016
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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