Can a Vocal Stimulus Provoke Spontaneous Breathing in an... | NCT02114996

Studies
Can a Vocal Stimulus Provoke Spontaneous Breathing in an Ischemic Stroke Patient Dependent on Mechanical Ventilation?

NCT02114996

Sponsor

The Baruch Padeh Medical Center, Poriya

Status

Unknown status

Last Update Posted

Apr 15, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Patients Ventilated by Mechanical Ventilation With Ischemic Stroke

Interventions

Not provided

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Aug 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Apr 13, 2014

First Submission Date that Met QC Criteria

Apr 13, 2014

First Posted Date

Apr 15, 2014Estimated

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

Apr 13, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arnon Blum, Director of an Internal Medicine Department, The Baruch Padeh Medical Center, PoriyaPrincipal Investigator

Lead Sponsor

The Baruch Padeh Medical Center, PoriyaOTHER_GOV

Collaborators

Not provided

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

Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.

Detailed Description

Vocal stimulation may encourage breathing in ventilated patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation that will be our control group.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
spontaneous breathing	we anticipate a better response and recurring spontaneous breathing in the treatment group.	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ischemic stroke men and women older than 18 years old and younger than 80 years old

Exclusion Criteria:

coma from other reasons other than ischemic stroke hemmorhagic stroke active malignancy renal failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients on mechanical ventilation

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided