Hip Fracture Surgery in Elderly Patients (HIPELD)

July 24, 2015 updated by: Air Liquide Santé International

An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • France
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble
      • Montpellier, France, 34295
        • Centre Hospitalier régional Universitaire de Montpellier
      • Paris, France, 75651
        • Groupe Hospitalier La Pitie-Salpetriere
      • Paris cedex 14, France, 75979
        • Groupe Hospitalier Cochin
      • Rennes, France, 35033
        • CHU Pontchaillou - Université de Rennes 1
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse
  • Germany
      • Aachen, Germany, 52074
        • University Hospital Aachen
      • Düsseldorf, Germany, 40225
        • . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaerinnen
  • Italy
      • Bologna, Italy, 40136
        • IRCCS Rizzoli Orthopaedic Institute
  • Spain
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Imperial College NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Xenon
60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
Drug: Xenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Other Names:
  • LENOXe
Active Comparator: Sevoflurane
1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
Drug: Sevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Time Frame: Four days
Four days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Time Frame: About 7 days
About 7 days
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Time Frame: four days
four days
Recovery Parameters
Time Frame: fifteen minutes
fifteen minutes
economic parameters
Time Frame: up to thirty days
up to thirty days
Safety Parameters
Time Frame: Up to thirty days
Serious Adverse Events, Adverse Events, laboratory parameters
Up to thirty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Liquide Santé International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OptumInsight

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mark COBURN, MD, University Hospital Aachen - Germany
  • Study Chair: Robert SANDERS, MD, Imperial College London - UK
  • Study Chair: Rolf ROSSAINT, MD, University Hospital Aachen - Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALMED-08-C2-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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