NCT01049958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

January 13, 2010

Last Update Submit

January 13, 2013

Conditions

Keywords

asynchronymechanical ventilationblunt trauma

Outcome Measures

Primary Outcomes (1)

  • Proportion of asynchronous breaths

    20 minutes during first 24 hours on ventilation and 20 minutes during weaning phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the Surgical and Neurosurgical Intensive Care Units at University Hospital, Cincinnati, OH, who require mechanical ventilation and are aged 18 years or older.

You may qualify if:

  • Trauma or surgical diagnosis
  • Patients requiring mechanical ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45267, United States

Location

Related Publications (4)

  • 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.

    PMID: 16896854BACKGROUND
  • 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.

    PMID: 7750336BACKGROUND
  • 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.

    PMID: 9032512BACKGROUND
  • 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.

MeSH Terms

Conditions

Patient-Ventilator AsynchronyWounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Bryce Robinson, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

July 1, 2009

Primary Completion

May 1, 2010

Study Completion

April 1, 2011

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations