Clinical trial NCT01009606: Cardiopulmonary Resuscitation Witnessing by a Relative
Official title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrest
Keywords: Out-of-hospital
Emergency
Cardiac arrest
Post-traumatic stress disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-11-09
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Percentage of relatives having a score of the Impact of Events Scale (IES) > 30
timeFrame: 3 months
Secondary outcomes:
measure: Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)
timeFrame: 3 and 12 months
measure: Psychological follow-up
timeFrame: 3 months
measure: Suicide
timeFrame: 3 and 12 months
measure: Medico-legal recourse
timeFrame: 12 months
measure: Quality of the cardiopulmonary resuscitation
timeFrame: day 0
measure: Questionnaire evaluating the stress of the medical and paramedical team
timeFrame: day 0
Other outcomes:
Locations:
city: Bobigny
country: France
facility: SAMU 93 - Hôpital Avicenne
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric ADNET, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.
citation: Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.
citation: Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.