An observational study in Orthostatic Hypotension, Orthostatic Intolerance and Postoperative Complications, sponsored by Copenhagen University Hospital, Hvidovre. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Copenhagen University Hospital, Hvidovre · Observational
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA
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.
155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.
This study's planned enrollment of 42 is below the median of 50 across 34 observational studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 76 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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)
Incidence of orthostatic intolerance
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Time frame: 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
Time frame: 6 hours postoperatively
Changes in systolic arterial pressure (SAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Measured in mL/min, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization
Measured in mmHg⋅min⋅mL-1
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization
Measured in mL, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during mobilization
Measured in ms, LiDCO-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Measured in arbitrary units (AU), Massimo apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Measured in %, NIRS-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Measured in %, NIRS-apparatus
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in haemoglobin (Hgb) concentration
Measured in millimoles/L
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in C-Reactive Protein
Measured in mg/L
Time frame: Preoperatively, 6 and 24 hours postoperatively
Pain score during mobilization
Measured by verbal rating scale (VRS) from 0 to 10
Time frame: Preoperatively, 6 and 24 hours postoperatively
Estimated bleeding
Measured in mL
Time frame: Preoperatively, 6 and 24 hours postoperatively
Opioid usage
Measured in mg
Time frame: Preoperatively, 6 and 24 hours postoperatively
Cumulative fluid administration and losses
Measured in mL
Time frame: Preoperatively, 6 and 24 hours postoperatively
Plan to share: No
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Copenhagen University Hospital, Hvidovre