Hip Fracture Surgery in Elderly Patients

Recruiting

• Source

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  Public Title	Hip Fracture Surgery in Elderly Patients
  Acronym	HIPELD
  Source of Record URL	http://clinicaltrials.gov/show/NCT01199276

• Trial

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  Health Condition(s) or Problem	Delirium
  Lay Summary	The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery. (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: - Elderly patient (= 75 years) - 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: - Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur) - 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
  Who cannot enter the trial	Inclusion Criteria: - Elderly patient (= 75 years) - 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: - Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur) - 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
  What will happen	Drug; Xenon; Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45); Xenon; LENOXe; Drug; Sevoflurane; Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air; Sevoflurane
  Primary aim	Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
  Secondary Aim	Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital; About 7 days; No; Sequential Organ Failure Assessment from day 1 to day 4 post-surgery; four days; No; Recovery Parameters; fifteen minutes; No; economic parameters; up to thirty days; No; Safety Parameters; Up to thirty days; Yes; Serious Adverse Events, Adverse Events, laboratory parameters
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	London

• Contact

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  Contact for Public Queries

  Joel GUITTET +33 1 39 07 20 68 joel.guittet@airliquide.com Mark COBURN, MD; Robert SANDERS, MD; Rolf ROSSAINT, MD Study Chair; Study Chair; Study Chair University Hospital Aachen - Germany; Imperial College London - UK; University Hospital Aachen - Germany

  Contact for Scientific Queries

  Pierre ALBALADEJO, MD; Principal Investigator; Xavier CAPDEVILA, MD; Principal Investigator; Olivier LANGERON, MD; Principal Investigator; Nadia ROSENCHER, MD; Principal Investigator; Hélène BELOEIL, MD; Principal Investigator; Vincent MINVILLE, MD; Principal Investigator; Rolf ROSSAINT, MD; Principal Investigator; Peter KIENBAUM, Prof.med.Dr; Principal Investigator; Oliver KUNITZ, Dr; Principal Investigator; Battista BORGHI, MD; Principal Investigator; Javier BELDA, MD; Principal Investigator; Glenn ARNOLD, MD; Principal Investigator