Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838706
• Other study ID #: HvidovreUH
• Status: Completed
• Phase: N/A
• First received: April 18, 2016
• Last updated: April 25, 2017
• Start date: May 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: April 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Delirium
• Hip Fractures

Intervention

Procedure:
• Surgery for hip fracture

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre, department of anesthesiology	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	Delay in diagnosting perioperative anemia	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
Primary	Perfusion index, periopertive anemia and delirium	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	Perfusion index as a predictor of early warning score (EWS)	Is there a relationship between low perfusion index an high EWS?	From admission up to and including the 3 postopertive day