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Completed

NCT Number: NCT02838706

Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels

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.

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Key information

Conditions

Anemia Confusion Delirium Hematologic Diseases Hemic and Lymphatic Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital Hvidovre, department of anesthesiology

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery for hip fracture

Procedure

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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?

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2016
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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