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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01178489
Other study ID # H-1-2010-FSP
Secondary ID
Status Completed
Phase N/A
First received August 9, 2010
Last updated September 21, 2011
Start date August 2010
Est. completion date January 2011

Study information

Verified date September 2011
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.


Description:

In this prospective, consecutive, observational cohort study we examine:

1. Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question "Why in PACU?", using a modified version of the national guidelines for patient observation in PACU.

2. The time spent in PACU with the modified version of the national guidelines for patient observation in PACU.

3. If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia

Exclusion Criteria:

- Bilateral arthroplasty

- Revision arthroplasty

- General anaesthesia

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • PACU Stay After THA Under Spinal Anaesthesia
  • PACU Stay After TKA Under Spinal Anaesthesia

Locations

Country Name City State
Denmark Hvidovre University Hospital Copenhagen Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to meet PACU discharge criteria 3 hours No
Secondary Actual discharge time from PACU 3 hours No
Secondary Clinical and logistic factors detaining patients in PACU 3 hours No
Secondary Potential complications at the surgical ward 24 hours Yes