Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization in Total Hip Arthroplasty (THA) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01089946
First received: March 17, 2010
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.


Condition
Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization After Primary Total Hip Arthroplasty

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Orthostatic intolerance [ Time Frame: 6 and 24 hours postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Orthostatic hypotension [ Time Frame: 6 and 24 hours postoperative ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing primary THA.

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Primary THA

Exclusion Criteria:

  • Alcoholism
  • Known orthostatic hypotension
  • Daily use of anxiolytic medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089946

Locations
Denmark
Hørsholm Hospital
Hørsholm, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Oeivind Jans, M.D. Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Oeivind Jans, M.D, Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01089946     History of Changes
Other Study ID Numbers: RH-4074
Study First Received: March 17, 2010
Last Updated: October 9, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Mobilization
Hip arthroplasty
cardiovascular

ClinicalTrials.gov processed this record on August 26, 2014