Cardiopulmonary Resuscitation Witnessing by a Relative

Phase 4

Completed

• Conditions: Cardiac Arrest
• Interventions: Other: Usual strategy; Other: Modified strategy

• Registration Number: NCT01009606
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 : Control : usual strategy	Usual strategy	-
Arm 2: Comparator : modified strategy	Modified strategy	-

Primary Outcome Measures

Name	Time	Method
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30	3 months

Secondary Outcome Measures

Name	Time	Method
Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)	3 and 12 months
Psychological follow-up	3 months
Suicide	3 and 12 months
Medico-legal recourse	12 months
Quality of the cardiopulmonary resuscitation	day 0
Questionnaire evaluating the stress of the medical and paramedical team	day 0

Trial Locations

Locations (1)

SAMU 93 - Hôpital Avicenne; 🇫🇷 Bobigny, Ile de France, France