Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
256 participants
INTERVENTIONAL
2010-09-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Xenon
60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
Xenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Sevoflurane
1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
Sevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
Interventions
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Xenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Sevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with planned hip fracture surgery within 48 hours after the hip fracture
* Patient willing and able to complete the requirements of this study including the signature of the written informed consent
Exclusion Criteria
* Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression)
* Brain trauma within 12 months prior to selection, history of stroke with residuals
* Patient suffering from delirium (CAM diagnosis) at selection
* Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial
* Patient with Mini-Mental State Examination (MMSE) score \< 24 at selection
* Patient known to susceptible to malignant hyperthermia
* Patient with elevated intra-cranial pressure
* Patient with a risk of high oxygen demand
* Patient with recent or ongoing myocardial infarction / damage
* Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function
* Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy
* Contra-indication (serious illness or medical conditions) for general anaesthesia
* Known allergy or hypersensitivity to any drugs administered during this clinical trial
* Previous participation in this clinical trial
* Participation in another clinical trial within 4 weeks prior to selection
* History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent
75 Years
ALL
No
Sponsors
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OptumInsight
UNKNOWN
Air Liquide Santé International
INDUSTRY
Responsible Party
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Principal Investigators
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Mark COBURN, MD
Role: STUDY_CHAIR
University Hospital Aachen - Germany
Robert SANDERS, MD
Role: STUDY_CHAIR
Imperial College London - UK
Rolf ROSSAINT, MD
Role: STUDY_CHAIR
University Hospital Aachen - Germany
Locations
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UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
Centre Hospitalier Régional Universitaire de Montpellier
Montpellier, , France
Groupe Hospitalier La Pitié-Salpêtriere
Paris, , France
Groupe Hospitalier COCHIN
Paris, , France
CHU Pontchaillou - Université de Rennes 1
Rennes, , France
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
University Hospital Aachen
Aachen, , Germany
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Klinikum Mutterhaus Der Borromaerinnen
Trier, , Germany
IRCCS Rizzoli Orthopaedic Institute
Bologna, , Italy
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Imperial College NHS Trust
London, , United Kingdom
Countries
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References
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Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.
Other Identifiers
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ALMED-08-C2-020
Identifier Type: -
Identifier Source: org_study_id
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