Cardiopulmonary Resuscitation Witnessing by a Relative (PRESENCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Usual strategy; Other: Modified strategy

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 Type: Interventional
• Enrollment (Actual): 570
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Bobigny, Ile de France, France, 93000
      • SAMU 93 - Hôpital Avicenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Frédéric ADNET, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 6, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 17, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Cardiac arrest; Emergency; Out-of-hospital; Post-traumatic stress disorder
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: P071239