Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)

Overview

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

Full Title of Study: “Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2020

Detailed Description

In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) > 20 mmHg or a drop >10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation. Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery. This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.

Interventions

  • Other: Standardized mobilization procedure
    • 5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)

Arms, Groups and Cohorts

  • Orthostatic intolerant (OI)
    • Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilization
  • Orthostatic tolerant (OT)
    • Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilization

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of orthostatic intolerance
    • Time Frame: 6 hours postoperatively
    • Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
  • Incidence of orthostatic hypotension
    • Time Frame: 6 hours postoperatively
    • Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization

Secondary Measures

  • Changes in systolic arterial pressure (SAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg, LiDCO-apparatus
  • Changes in diastolic arterial pressure (DAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg, LiDCO-apparatus
  • Changes in mean arterial pressure (MAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg, LiDCO-apparatus
  • Changes in cardiac output (CO) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mL/min, LiDCO-apparatus
  • Changes in systemic vascular resistance (SVR) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg⋅min⋅mL-1
  • Changes in stroke volume (SV) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mL, LiDCO-apparatus
  • Changes in heart rate variability (HRV) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in ms, LiDCO-apparatus
  • Changes in peripheral perfusion index (PPI) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in arbitrary units (AU), Massimo apparatus
  • Changes in cerebral perfusion (ScO2) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in %, NIRS-apparatus
  • Changes in muscular perfusion (SmO2) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in %, NIRS-apparatus
  • Changes in haemoglobin (Hgb) concentration
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in millimoles/L
  • Changes in C-Reactive Protein
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mg/L

Participating in This Clinical Trial

Inclusion Criteria

  • Age >18 years and – Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting. – Patients that speak and understand Danish – Written informed consent Exclusion Criteria:

  • Pre-existing orthostatic hypotension or intolerance – Alcohol or substance abuse – everyday treatment with either anxiolytic or antipsychotic medicine – Cognitive dysfunction – If surgery was converted to general anesthesia or total knee arthroplasty.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Copenhagen University Hospital, Hvidovre
  • Collaborator
    • Henrik Kehlet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louise Bundsgaard Andersen, Undergraduate Student – Copenhagen University Hospital, Hvidovre
  • Overall Contact(s)
    • Louise Bundsgaard Andersen, medical student, +45 41161599, louise.bundsgaard.andersen.01@regionh.dk

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