Cardiopulmonary Resuscitation Witnessing by a Relative

NCT ID: NCT01009606

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1 : Control : usual strategy

Group Type ACTIVE_COMPARATOR

Usual strategy

Intervention Type OTHER

Usual strategy

Arm 2: Comparator : modified strategy

Group Type EXPERIMENTAL

Modified strategy

Intervention Type OTHER

Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Interventions

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Usual strategy

Usual strategy

Intervention Type OTHER

Modified strategy

Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric ADNET, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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SAMU 93 - Hôpital Avicenne

Bobigny, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27618681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24852952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23484827 (View on PubMed)

Other Identifiers

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P071239

Identifier Type: -

Identifier Source: org_study_id

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