Cardiopulmonary Resuscitation Witnessing by a Relative

Cardiac Arrest Clinical Trial

— PRESENCE  

Official title:

Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009606
• Other study ID #: P071239
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2009
• Last updated: January 17, 2013
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Other:
• Usual strategy
Usual strategy
• Modified strategy
Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Locations

Country	Name	City	State
France	SAMU 93 - Hôpital Avicenne	Bobigny	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of relatives having a score of the Impact of Events Scale (IES) > 30		3 months	No
Secondary	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	Yes
Secondary	Psychological follow-up		3 months	Yes
Secondary	Suicide		3 and 12 months	Yes
Secondary	Medico-legal recourse		12 months	Yes
Secondary	Quality of the cardiopulmonary resuscitation		day 0	Yes
Secondary	Questionnaire evaluating the stress of the medical and paramedical team		day 0	Yes