Safety Study to Evaluate Intracranial Pressure During Hig... | NCT00279097

Studies
Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation

NCT00279097

Sponsor

Hill-Rom

Status

Terminated

Last Update Posted

Nov 16, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Intracranial Pressure

Interventions

High Frequency Chest Wall Oscillation

Countries

United States

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

Nov 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Jan 17, 2006

First Submission Date that Met QC Criteria

Jan 17, 2006

First Posted Date

Jan 19, 2006Estimated

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

Nov 15, 2006

Last Update Posted Date

Nov 16, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.

Detailed Description

This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
High Frequency Chest Wall Oscillation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracranial pressure
SpO2
Heart rate
Mean arterial pressure (MAP)
Arterial blood gases (ABGs)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
On ventilator
Arterial line in place
Age equal to or greater than 18
Admitted to neurotrauma intensive care unit (ICU)

Exclusion Criteria:

Inability to obtain informed consent
Unstable spinal cord injury
ICP > 20 mmHg sustained for > 5 minutes
Hemodynamic instability within the prior 12 hours
Active hemoptysis
Hemothorax
New onset, unstable arrhythmia
Enrollment in another interventional study
Aneurysm that has not been clipped or coiled
Coagulopathic head injury subjects

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert L Levine, MD	University of Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas at Houston/Memorial Hermann Hospital		Houston	Texas	77030	United States

Intervention Browse Module

MeSH Terms

ID	Term
D035641	Chest Wall Oscillation

Ancestor Terms

ID	Term
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided