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

被引：46

作者：

Kowark, Ana ^{[1
]}

Adam, Christian ^{[2
]}

Ahrens, Joerg ^{[3
]}

Bajbouj, Malek ^{[4
]}

Bollheimer, Cornelius ^{[5
]}

Borowski, Matthias ^{[6
]}

Dodel, Richard ^{[7
]}

Dolch, Michael ^{[8
]}

Hachenberg, Thomas ^{[9
]}

Henzler, Dietrich ^{[10
]}

Hildebrand, Frank ^{[11
]}

Hilgers, Ralf-Dieter ^{[12
]}

Hoeft, Andreas ^{[13
]}

Isfort, Susanne ^{[14
]}

Kienbaum, Peter ^{[15
]}

Knobe, Mathias ^{[11
]}

Knuefermann, Pascal ^{[16
]}

Kranke, Peter ^{[17
]}

Laufenberg-Feldmann, Rita ^{[18
]}

Nau, Carla ^{[19
]}

Neuman, Mark D. ^{[20
]}

Olotu, Cynthia ^{[21
]}

Rex, Christopher ^{[22
]}

Rossaint, Rolf ^{[1
]}

Sanders, Robert D. ^{[23
]}

Schmidt, Rene ^{[24
]}

Schneider, Frank ^{[25
,26
]}

Siebert, Hartmut ^{[27
]}

Skorning, Max ^{[28
]}

Spies, Claudia ^{[29
]}

Vicent, Oliver ^{[30
]}

Wappler, Frank ^{[31
]}

Wirtz, Dieter Christian ^{[32
]}

Wittmann, Maria ^{[13
]}

Zacharowski, Kai ^{[33
]}

Zarbock, Alexander ^{[34
]}

Coburn, Mark ^{[1
]}

Roehl, Anna B. ^{[1
]}

Van Waesberghe, Julia ^{[1
]}

Ziemann, Sebastian ^{[1
]}

Fitzner, Christina ^{[12
]}

Batista, Joao Pedro ^{[5
]}

Freitag, Mathias ^{[5
]}

Dietrich, Claudia ^{[25
]}

Kalvelage, Christina ^{[14
]}

Grohe, Christina ^{[14
]}

Schiemann, Alexander ^{[29
]}

Schmidt, Katrin ^{[29
]}

Reichert, Dennis ^{[16
]}

Renziehausen, Fenja ^{[16
]}

机构：

[1] Rhein Westfal TH Aachen, Med Fac, Dept Anaesthesiol, Aachen, Germany

[2] Klinikverbund St Antonius & St Josef GmbH, Dept Anaesthesiol Intens Care & Pain Therapy, Wuppertal, Germany

[3] Hannover Med Sch, Dept Anaesthesiol & Intens Care, Hannover, Germany

[4] Charite Ctr Neurol Neurosurg & Psychiat, Psychiat & Affect Neurosci, Campus Benjamin Franklin, Berlin, Germany

[5] Rhein Westfal TH Aachen, Med Fac, Dept Geriatr Med, Aachen, Germany

[6] Univ Munster, Inst Biostat & Clin Res, Munster, Germany

[7] Univ Hosp Essen, Dept Geriatr, Essen, Germany

[8] Ludwig Maximilians Univ Munchen, Dept Anaesthesiol, Munich, Germany

[9] Univ Hosp Magdeburg, Dept Anaesthesiol & Intens Care, Magdeburg, Germany

[10] Ruhr Univ Bochum, Klinikum Herford, Dept Anaesthesiol Surg Intens Care Emerge, Herford, Germany

[11] Rhein Westfal TH Aachen, Med Fac, Dept Orthopaed Trauma Surg, Aachen, Germany

[12] Rhein Westfal TH Aachen, Med Fac, Dept Med Stat, Aachen, Germany

[13] Univ Hosp Bonn, Dept Anaesthesiol & Operat Intens Care Med, Bonn, Germany

[14] Rhein Westfal TH Aachen, Med Fac, Ctr Translat & Clin Res Aachen CTC A, Aachen, Germany

[15] Univ Hosp Dusseldorf, Dept Anaesthesiol, Dusseldorf, Germany

[16] Gemeinschaftskrankenhaus Bonn, Dept Anaesthesiol, Bonn, Germany

[17] Univ Hosp Wurzburg, Dept Anaesthesiol, Wurzburg, Germany

[18] Johannes Gutenberg Univ Mainz, Dept Anaesthesiol, Univ Med Ctr, Mainz, Germany

[19] Univ Hosp Schleswig Holstein, Dept Anaesthesiol & Intens Care, Lubeck, Germany

[20] Univ Penn, Dept Anaesthesiol & Crit Care, Philadelphia, PA USA

[21] Univ Hosp Hamburg Eppendorf, Dept Geriatr Anaesthesiol, Hamburg, Germany

[22] Reutlingen Hosp GMBH, Dept Anaesthesiol & Intens Care, Reutlingen, Germany

[23] Univ Wisconsin, Dept Anesthesiol, Madison, WI USA

[24] Rhein Westfal TH Aachen, Med Fac, Dept Psychiat Psychotherapy & Psychosomat, Stuttgart, Germany

[25] Rhein Westfal TH Aachen, Med Fac, Dept Psychiat Psychotherapy & Psychosomat, Aachen, Germany

[26] Res Ctr Julich, INM 10, Julich, Germany

[27] Aktionsbundnis Patientensicherheit eV, Berlin, Germany

[28] Med Advisory Serv Social Hlth Insurance, Sect Patient Safety, Essen, Germany

[29] Charite Univ Med Berlin, Dept Anaesthesiol, Berlin, Germany

[30] Univ Hosp Dresden, Dept Anaesthesiol & Intens Care, Dresden, Germany

[31] Univ Witten Herdecke, Dept Anaesthesiol & Operat Intens Care, Witten, Germany

[32] Univ Hosp Bonn, Dept Orthopaed & Trauma Surg, Bonn, Germany

[33] Univ Hosp Frankfurt, Dept Anaesthesiol Intens Care & Pain Therapy, Frankfurt, Germany

[34] Univ Hosp Muenster, Dept Anaesthesiol Intens Care & Pain Therapy, Munster, Germany

[35] Marienhosp Stuttgart, Dept Anaesthesiol Intens Care & Pain Therapy, Stuttgart, Germany

来源：

BMJ OPEN | 2018年 / 8卷 / 10期

关键词：

LENGTH-OF-STAY; POSTOPERATIVE DELIRIUM; MORTALITY; MANAGEMENT; SURGERY; RELIABILITY; VALIDATION; AUDIT; SCALE; MODE;

D O I：

10.1136/bmjopen-2018-023609

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Hip 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 analysis The 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 dissemination iHOPE 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.

引用

页数：11

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