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

Intracranial Pressure Clinical Trial

Official title:

A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00279097
• Other study ID #: CR-0038
• Status: Terminated
• Phase: N/A
• First received: January 17, 2006
• Last updated: November 15, 2006
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: November 2006
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intracranial Pressure

Intervention

Device:
• High Frequency Chest Wall Oscillation

Locations

Country	Name	City	State
United States	University of Texas at Houston/Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure
Primary	SpO2
Primary	Heart rate
Primary	Mean arterial pressure (MAP)
Primary	Arterial blood gases (ABGs)