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RESEARCH PRODUCT
Improve hip fracture outcome in the elderly patient (iHOPE) : A study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia
Ana KowarkChristian AdamFrank HildebrandRalf-dieter HilgersAndreas HoeftSusanne IsfortPeter KienbaumMathias KnobePascal KnuefermannPeter KrankeRita Laufenberg-feldmannCarla NauJörg AhrensMark D. NeumanCynthia OlotuChristopher RexRolf RossaintRobert D. SandersRene SchmidtFrank SchneiderHartmut SiebertMax SkorningClaudia SpiesMalek BajboujOliver VicentFrank WapplerDieter Christian WirtzMaria WittmannKai ZacharowskiAlexander ZarbockMark CoburnIhope Study GroupAnna B. RoehlJulia VanwaesbergheCornelius BollheimerSebastian ZiemannChristina FitznerJoao Pedro BatistaMathias FreitagClaudia DietrichChristina KalvelageChristina GroheAlexander SchiemannKatrin SchmidtDennis ReichertMatthias BorowskiFenja RenziehausenClaudia NeumannFenna PostMaximilian SchäferThomas MüllerAnne OsmersJan MersmannPatrick MeybohmRainer KiefmannAnn-kathrin RiegelRichard DodelWolfgang KoppertHans-peter ReiffenMarion FernerFlorian HeidMira KüllmarMelanie MeerschBernhard ZwisslerHansjörg HaasAgneta PeszkoChristoph IliesMichael DolchUlrich C. LienerCarolin MauneStefanie WehmeierAntonia HelfYvonne JeltingThomas HachenbergDietrich Henzlersubject
Male1682medicine.medical_specialtyArthroplasty Replacement HipMedizinAnesthesia GeneralAnesthesia Spinallaw.inventionAnaesthesia03 medical and health sciencesClinical Trial Protocols as TopicPostoperative Complications0302 clinical medicineRandomized controlled trial030202 anesthesiologylawPragmatic Clinical Trials as TopicProtocolClinical endpointHumansMulticenter Studies as TopicMedicineGeneral anaesthesia1506ddc:610030212 general & internal medicineAgedRandomized Controlled Trials as TopicPain PostoperativeHip fracturegeriatric medicineHip Fracturesbusiness.industryMedical recordanaesthesia in orthopaedicsGeneral MedicinePerioperativeMiddle Agedmedicine.diseaseanaestheticsClinical trialTelephone interviewResearch DesignPhysical therapyFemalebusinessdescription
IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60.Ethics and disseminationiHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals.Trial registration numberDRKS00013644; Pre-results
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-10-01 |