Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients

NCT ID: NCT01049958

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient/Ventilator Asynchrony

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryce Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.

Reference Type BACKGROUND
PMID: 16896854 (View on PubMed)

Fabry B, Guttmann J, Eberhard L, Bauer T, Haberthur 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. doi: 10.1378/chest.107.5.1387.

Reference Type BACKGROUND
PMID: 7750336 (View on PubMed)

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. doi: 10.1183/09031936.97.10010177.

Reference Type BACKGROUND
PMID: 9032512 (View on PubMed)

Robinson BR, Blakeman TC, Toth P, Hanseman DJ, Mueller E, Branson RD. Patient-ventilator asynchrony in a traumatically injured population. Respir Care. 2013 Nov;58(11):1847-55. doi: 10.4187/respcare.02237. Epub 2013 Mar 19.

Reference Type DERIVED
PMID: 23513248 (View on PubMed)

Other Identifiers

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Robinson-2009-01

Identifier Type: -

Identifier Source: org_study_id

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