Hip Fracture Surgery in Elderly Patients | Completed
Hip Fracture Surgery in Elderly Patients
HIPELD
Trial Source

Health Conditions
  • Delirium
Completed
Recruitment Status
NCT01199276
Primary Trial ID Number
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.
Primary Outcome Measures
  • Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery; Four days
Secondary Outcome Measures
  • Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital; About 7 days; Sequential Organ Failure Assessment from day 1 to day 4 post-surgery; four days; Recovery Parameters; fifteen minutes; economic parameters; up to thirty days; Safety Parameters; Up to thirty days
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Belgium; France; Germany; Italy; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
75 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; Xenon; Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45); [Xenon]; Drug; Sevoflurane; Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air; [Sevoflurane]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
HIPELD
Scientific Title
An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Secondary Trial Identifying Number
Sorry, this information is not available
Website
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Study Funded By
Air Liquide Santé International
Funder Type
Sorry, this information is not available
Study Sponsored By
Air Liquide Santé International
Study Also Sponsored By
OptumInsight
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

09 Sep 2010

Last Updated

24 Jul 2015

Date Record Refreshed on UKCTG

01 Aug 2015