Heart Rate Variability During Sleep After Fast-track Surgery
1 other identifier
observational
10
1 country
1
Brief Summary
Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances, after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental analysis of heart rate variablity after arousals during sleep. We compared preoperative and postoperative results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
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
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 14, 2011
December 1, 2011
5 months
July 11, 2011
December 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
heart rate variability
heart rate variability measured 5 beats before arousel and 15 beats after arousel in different sleep stages.
24 hours
Study Arms (2)
patients
patient characteristics are specified in H-2-2010-011
controls
age matched to patients described in protocol H-2-2010-011
Eligibility Criteria
We selected patients undergoing fasttrack hip and knee arthoplasty in fast-track setip. The underwent sleep monotoring for 1 preoperative night and continously during hospitalisation, and for 1 night at home after surgery.
You may qualify if:
- Age \> 60 years
You may not qualify if:
- surgery within the last 2 months
- known sleep disorder (eg. sleep apnea)
- daily beta blocker treatment
- daily dopamine treatment
- This protocol only concentrates on the healthy controls for the patient described in H-2-2010-011.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lene Krenklead
Study Sites (1)
Rigshospitalet
Copenhagen, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Krenk, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 14, 2011
Record last verified: 2011-12