Bone cement implantation syndrome, Fat embolism Fat embolism
Conditions
Interventions
The surgical and anesthesiologic procedures are carried out as usual, with no changes implemented. What is added to the procedure is performing the external femoral ultrasound:To minimize intraoperati
ensuring it does not interfere with the sterile surgical field. As such, there is no increased risk of infection due to the ultrasound. Additionally, patients will not need to be repositioned or undre
External ultrasound assessments wil
Sponsors
Spaarne Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients warranting cemented total knee arthroplastyMinimum age of 18 yearsWritten and signed informed consent
Exclusion criteria
Exclusion criteria: Obesity (BMI>35 kg/m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence of embolic events and grading of the embolic events. Femoral embolic events will be monitored and recorded using external femoral ultrasound from 5 minutes before cementation until the end of the surgery. The observation of maximum grade of embolic events will be classified according to an established criterion with the following echogenic patterns:18Grade 0: no emboliGrade 1: a few fine emboliGrade 2: a cascade of fine emboli or embolic masses less than 5 mm in diameter and the right atrium opacified with echogenic materialsGrade 3: fine emboli mixed with large embolic masses greater than 5 mm in diameter or serpentine emboli | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoint will be the occurrence of overall BCIS:Yes:SpO2 <94% after cementation up until skin closure, AND/ORFall in SBP fall > 20% after cementation up until skin closureNo.Tertiary study outcome: The severity of BCIS according to the following classification:Grade 1: moderate hypoxia (SpO2 <94%) or hypotension (fall in SBP > 20% and < 40%), or both Grade 2: severe hypoxia (SpO2 <88%) or hypotension (fall in SBP > 40%), or both, or unexpected loss of consciousnessGrade 3: cardiovascular collapse requiring CPRAll parameters will be recorded at 2-minute intervals. Following cementation, measurements will be taken every minute for a duration of 10 minutes. The aforementioned parameters will be assessed non-invasively using an automatic upper-arm blood pressure monitor and a pulse oximeter.Determinant: Femoral embolic events will be monitored and recorded using external femoral ultrasound from 5 minutes before cementation until the end of the surgery. The observation of maximum grade of embolic events will be classified according to an established criterion with the echogenic patterns as described in 5.1.1. | — |
Countries
Netherlands
Contacts
Public ContactKE Brokke
Spaarne Gasthuis
Outcome results
None listed