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The relation of pre- and postoperative heart rate variability and baroreflex sensitivity with orthostatic intolerance in patients undergoing primary total hip or knee replacement


- candidate number24326
- NTR NumberNTR5851
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-mei-2016
- Secondary IDsHRV-studie 
- Public TitleThe relation of pre- and postoperative heart rate variability and baroreflex sensitivity with orthostatic intolerance in patients undergoing primary total hip or knee replacement
- Scientific TitleThe relation of pre- and postoperative heart rate variability and baroreflex sensitivity with orthostatic intolerance in patients undergoing primary total hip or knee replacement NL: De relatie tussen pre- en postoperatieve hartslag variatie en baroflex gevoeligheid met orthostatische intolerantie bij operatie patiënten voor een totale heup of knie prothese
- ACRONYMHRV
- hypothesisWe hypothesize that a low heart rate variability and baroreflex sensitivity in the pre- or postoperative phase are associated with orthostatic intollerance when compared to subjects with normal heart rate variability.
- Healt Condition(s) or Problem(s) studiedOrthostatic hypotension, Hip-knee replacement
- Inclusion criteriaScheduled for hip or knee replacement surgery
Standard spinal anesthesia
Age between 18–90 years
Informed consent
- Exclusion criteriaHeart rhythm other than sinus
History of orthostatic intolerance prior to surgery
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-mei-2017
- Target number of participants100
- InterventionsNone
- Primary outcomeHeart rate variability
- Secondary outcomebaroreflex sensitivity, orthostatic hypotension system assessment(OHSA) and orthostatic hypotension daily activity scale (OHDAS)
- Timepointsnone
- Trial web siteN.A.
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. van Beek
- CONTACT for SCIENTIFIC QUERIES R. van Beek
- Sponsor/Initiator Westfriesgasthuis Hoorn
- Funding
(Source(s) of Monetary or Material Support)
Westfriesgasthuis Hoorn
- PublicationsDe resultaten zullen gepubliceerd worden
- Brief summary Background: Glenohumeral (shoulder) dislocations are the most common large joint dislocations seen in the emergency department (ED). They cause pain, often severe, and require timely interventions to minimize discomfort and tissue damage. Commonly used reposition or relocation techniques often involve traction and/or leverage. These techniques have high success rates but may be painful and time consuming. They may also cause complications. Recently, other techniques—the biomechanical reposition techniques (BRT)—have become more popular since they may cause less pain, require less time and cause fewer complications. To our knowledge, no research exists comparing the various BRTs.

Objective: To establish which BRT or BRT combination is fastest, least painful and associated with the lowest complication rate for adult ED patients with anterior glenohumeral dislocations (AGDs).

Methods: Adults presenting to the participating EDs with isolated AGDs, as determined by radiographs, will be randomised to one of three BRTs - Cunningham, modified Milch or scapular manipulation.

Main study parameters/endpoints:
 ED length-of- stay
 Patients’ self-report of pain
Secondary study parameters/endpoints: 
 Procedure times
 Need for analgesic and/or sedative medications
 Iatrogenic complications
 Rates of successful reduction

Discussion: Non-biomechanical AGD repositioning techniques based on traction and/or leverage are inherently painful and potentially harmful. We believe that the three BRTs used in this study are more physiologic, more patient-friendly, less likely to cause pain, more time efficient and less likely to produce complications. By comparing these three techniques we hope to improve the care provided to adults with acute AGDs by reducing their ED length-of- stay and minimizing pain and procedure- related complications. We also hope to define which of the three BRTs is quickest, most likely to be successful and least likely to require sedative or analgesic medications to achieve reduction.

Keywords: Anterior shoulder dislocation, glenohumeral dislocation, biomechanical reposition techniques, Cunningham, modified Milch, scapular manipulation technique, length-of- stay, emergency department, reduction rate
- Main changes (audit trail)
- RECORD8-mei-2016 - 6-jul-2016


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