NCT00571623

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 9, 2014

Status Verified

August 1, 2008

Enrollment Period

6 months

First QC Date

December 10, 2007

Last Update Submit

July 8, 2014

Conditions

Keywords

Brain InjuryIntracranial hypertensionHuman subjectsNursing care

Outcome Measures

Primary Outcomes (1)

  • Intracranial pressure

    1 hour

Study Arms (1)

1

All subjects act as their own contral

Other: Chest Physiotherapy

Interventions

10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 subjects with a neurological diagnosis and current ICP in situ.

You may qualify if:

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

You may not qualify if:

  • spinal cord injury such that CPT is not desired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mission Hospital

Mission Viejo, California, 92691, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Related Publications (7)

  • 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. doi: 10.1097/00003246-200209000-00029.

    PMID: 12352052BACKGROUND
  • Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. doi: 10.1016/j.ccell.2004.03.005.

    PMID: 15358383BACKGROUND
  • 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. doi: 10.1007/s12028-007-0015-y.

    PMID: 17522792BACKGROUND
  • Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. doi: 10.1097/00044067-200510000-00007.

    PMID: 16269895BACKGROUND
  • 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.

    PMID: 11855245BACKGROUND
  • Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. doi: 10.1097/00044067-200510000-00003.

    PMID: 16269891BACKGROUND
  • Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. No abstract available.

    PMID: 9677936BACKGROUND

MeSH Terms

Conditions

Brain InjuriesIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • DaiWai M Olson, Phd RN CCRN

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 9, 2014

Record last verified: 2008-08

Locations