NCT01304056

Brief Summary

Respiratory muscles seem to be activating differently in critically ill patients than in healthy persons. Needle electrodes would provide artefact-free signal information about muscle activation. However, needle recordings are an invasive technique which limits its feasibility in clinical setting. Intention of this study is to investigate if surface electromyography could be used to measure recruitment patterns of ventilatory muscles.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Status
withdrawn

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

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

Same day

First QC Date

February 24, 2011

Last Update Submit

October 8, 2013

Conditions

Ventilatory Physiology

Keywords

Ventilatory physiology

Study Arms (2)

Critically ill patients

Patients that are treated in intensive care unit and given ventilatory therapy.

Device: Ventilatory therapy

Interventional volunteer group

Healthy volunteers

Interventions

Ventilatory therapyDEVICE
Critically ill patients

Eligibility Criteria

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

Adult population \> 18 years of age

You may qualify if:

  • \> 18 years of age

You may not qualify if:

  • brain death of injury
  • high spinal cord injury
  • severe ARDS (static compliance below 40, PFI below 150)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jyrki Tenhunen, MD, PhD

    Critical Care Medicine Research Group, Tampere University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 9, 2013

Record last verified: 2013-10