Skip to main content
OpenTrials
Completed

NCT Number: NCT01049958

Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients

This study will examine the prevalence of patient-ventilator asynchrony and its determinants. Mechanically ventilated trauma patients often experience asynchrony when their pattern of breathing does not match the triggering of a mechanical ventilator.

Asynchrony is thought to be more common in delirious patients, patients with chronic lung disease and those who are heavily sedated. The study will examine the relationship between (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Cincinnati, Ohio, 45267, United States

About this study

This is a prospective observational study to determine the prevalence of patient/ventilator asynchrony in a cohort of trauma and surgical patients. There will be two 20-minute periods of observation. The first will be during the first 24 hours of mechanical ventilation and the second will take place when the patient is being weaned from the ventilator and is triggering half or more of all ventilator breaths.

The study team will use computer-captured waveforms to determine the proportion of all breaths that are asynchronous. This proportion is the primary outcome variable of the study.

The study hypothesis is that the proportion of asynchronous breaths is higher in patients with higher levels of sedation, as measured by the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Methods for the Intensive Care Unit (CAM-ICU). This hypothesis will be tested using repeated measures analysis of variance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Trauma or surgical diagnosis
  • Patients requiring mechanical ventilation

Exclusion criteria

  • Patients with no spontaneous breathing efforts due to injury or chemical paralysis
  • Patients with leaks in the patient ventilator system precluding evaluation of waveforms

Treatment and study plan

Primary outcomes

  1. Proportion of asynchronous breaths

    Time frame: 20 minutes during first 24 hours on ventilation and 20 minutes during weaning phase

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Prevalence of Patient Ventilator Asynchrony in Trauma and Surgical Patients

Acronym: Asynchrony

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 15, 2010
Registry last updated
Jan 15, 2013

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.

Published trials that share one or more normalized conditions with this study.