Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels

April 25, 2017 updated by: Christopher Clemmesen, Hvidovre University Hospital

Contionuous Perioperative Hemoglobin and Perfusion Index Measurements in Elderly Patients With Hip Fracture and Post Operative Delirium

The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion index and prolong perioperative anemia and the potential impact on perioperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Immediately after admission and diagnosis of a hip fracture the patients will be monitored with Masimo SpHb. The Patients will be continuously measured until the third day after surgery. The Monitors Hb and PI data but not the SpO2% will be blinded to all participating healthcare personnel.The first three postopertive days the patiens will daily be examined to determined it they have developed delirium.

All perioperativ complications in that period will be monitored.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital Hvidovre, department of anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The subjects are patients age ≥ 65 years requiring surgery for a hip fracture.

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • Primary hip fracture requiring surgery
  • Patients able to give informed consent
  • Patients who are able to undergo the Hospitals standardized fast track
  • Perioperative care regimen for hip fracture including are pre operative placed epidural

Exclusion Criteria:

  • Patients who can not co-operate to have a sensor attach to the finger continuous for 4 days.
  • Patients who has allergy to the bandage that is used to attach the sensor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly with hip fracture
The subjects are patients age ≥ 65 years requiring surgery for a hip fracture
Procedure: Surgery for hip fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay in diagnosting perioperative anemia
Time Frame: From admission up to and including the 3 postopertive day
Description of lag time between detection of anaemia by SpHb and Hb by blood sampling/transfusion
From admission up to and including the 3 postopertive day
Perfusion index, periopertive anemia and delirium
Time Frame: From admission up to and including the 3 postopertive day
The relation between average perioperative perfusion index, cumulated perioperative anemia over time and patient outcome in the form of medical complications, mortality, delirium and LOS.
From admission up to and including the 3 postopertive day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion index as a predictor of early warning score (EWS)
Time Frame: From admission up to and including the 3 postopertive day
Is there a relationship between low perfusion index an high EWS?
From admission up to and including the 3 postopertive day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HvidovreUH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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