Automated Chest Physiotherapy to Improve Outcomes in Neuro

Brain Injury Clinical Trial

— ACTION-ICP  

Official title:

Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571623
• Other study ID #: Pro00001842
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: July 8, 2014
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: August 2008
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.

Description:

The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.

1. The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.

2. The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study.

3. ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed

Exclusion Criteria:

• spinal cord injury such that CPT is not desired

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Intracranial Hypertension

Intervention

Other:
• Chest Physiotherapy
10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Mission Hospital	Mission Viejo	California
United States	WakeMed Hospital	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Neuroscience Nursing Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. Review. — View Citation

Bader MK, Palmer S. Keeping the brain in the zone. Applying the severe head injury guidelines to practice. Crit Care Nurs Clin North Am. 2000 Dec;12(4):413-27. Review. — View Citation

Elf K, Nilsson P, Enblad P. Outcome after traumatic brain injury improved by an organized secondary insult program and standardized neurointensive care. Crit Care Med. 2002 Sep;30(9):2129-34. — View Citation

Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. Review. — View Citation

Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. Review. — View Citation

Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. Review. — View Citation

Olson DM, Thoyre SM, Turner DA, Bennett S, Graffagnino C. Changes in intracranial pressure associated with chest physiotherapy. Neurocrit Care. 2007;6(2):100-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure		1 hour	Yes