Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients

Patient/Ventilator Asynchrony Clinical Trial

— Asynchrony  

Official title:

Prevalence of Patient Ventilator Asynchrony in Trauma and Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049958
• Other study ID #: Robinson-2009-01
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: January 13, 2013
• Start date: July 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Patient/Ventilator Asynchrony

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fabry B, Guttmann J, Eberhard L, Bauer T, Haberthür C, Wolff G. An analysis of desynchronization between the spontaneously breathing patient and ventilator during inspiratory pressure support. Chest. 1995 May;107(5):1387-94. — View Citation

Nava S, Bruschi C, Fracchia C, Braschi A, Rubini F. Patient-ventilator interaction and inspiratory effort during pressure support ventilation in patients with different pathologies. Eur Respir J. 1997 Jan;10(1):177-83. — View Citation

Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. Epub 2006 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of asynchronous breaths		20 minutes during first 24 hours on ventilation and 20 minutes during weaning phase	No