How to Study Ventilatory Physiology With the Help of Surf... | NCT01304056

Studies
How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings

NCT01304056

Sponsor

Tampere University Hospital

Status

Withdrawn

Last Update Posted

Oct 9, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Ventilatory Physiology

Interventions

Ventilatory therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Administrative reasons

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Feb 24, 2011

First Submission Date that Met QC Criteria

Feb 24, 2011

First Posted Date

Feb 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Critically ill patients		Patients that are treated in intensive care unit and given ventilatory therapy.	Device: Ventilatory therapy
Interventional volunteer group		Healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventilatory therapy	Device		Critically ill patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years of age

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult population > 18 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jyrki Tenhunen, MD, PhD	Critical Care Medicine Research Group, Tampere University Hospital	Study Director

Locations

Not provided