Heart Rate Variability During Sleep After Fast-track Surgery | NCT01393236

Studies
Heart Rate Variability During Sleep After Fast-track Surgery

NCT01393236

Sponsor

Lene Krenk

Status

Completed

Last Update Posted

Dec 14, 2011Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Heart Rate Variablity

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 12, 2011

First Posted Date

Jul 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients		patient characteristics are specified in H-2-2010-011
controls		age matched to patients described in protocol H-2-2010-011

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heart rate variability	heart rate variability measured 5 beats before arousel and 15 beats after arousel in different sleep stages.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria (for the control group):

Age > 60 years

Exclusion criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene Krenk, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark