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Cardiopulmonary Resuscitation Witnessing by a Relative (PRESENCE)

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ClinicalTrials.gov Identifier: NCT01009606
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: Usual strategy Other: Modified strategy Phase 4

Detailed Description:

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest
Study Start Date : November 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Cardiac Arrest
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm 1 : Control : usual strategy Other: Usual strategy
Usual strategy
Experimental: Arm 2: Comparator : modified strategy Other: Modified strategy
Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation


Outcome Measures

Primary Outcome Measures :
  1. Percentage of relatives having a score of the Impact of Events Scale (IES) > 30 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG) [ Time Frame: 3 and 12 months ]
  2. Psychological follow-up [ Time Frame: 3 months ]
  3. Suicide [ Time Frame: 3 and 12 months ]
  4. Medico-legal recourse [ Time Frame: 12 months ]
  5. Quality of the cardiopulmonary resuscitation [ Time Frame: day 0 ]
  6. Questionnaire evaluating the stress of the medical and paramedical team [ Time Frame: day 0 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient victim of a cardiac arrest and resuscitation initiated
  • Occurrence of cardiac arrest at home
  • Presence of a relative :

    • husband or spouse
    • father or mother
    • son or daughter
    • brother or sister
  • Patient's age ≥ 18 years
  • Relative's age ≥ 18 years
  • Consent of the relative to the participation in the study

Exclusion Criteria:

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009606


Locations
France
SAMU 93 - Hôpital Avicenne
Bobigny, Ile de France, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01009606     History of Changes
Other Study ID Numbers: P071239
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: December 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Out-of-hospital
Emergency
Cardiac arrest
Post-traumatic stress disorder

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases