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

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Orthostatic Hypotension; Orthostatic Intolerance
• Intervention / Treatment: Other: Standardized mobilization procedure

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.

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre Hospital
    • Contact: Louise Bundsgaard Andersen, Medical student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria.

Patients were eligible to enroll in the study if they were >18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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)
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	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score during mobilization	Measured by verbal rating scale (VRS) from 0 to 10	Preoperatively, 6 and 24 hours postoperatively
Estimated bleeding	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Opioid usage	Measured in mg	Preoperatively, 6 and 24 hours postoperatively
Cumulative fluid administration and losses	Measured in mL	Preoperatively, 6 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: Kehlet, Henrik, M.D., Ph.D.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2019
• Primary Completion (ANTICIPATED): March 31, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Postoperative Complications; Hypotension, Orthostatic; Orthostatic Intolerance
• Other Study ID Numbers: H-19063289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No