- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00628693
Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest (Q-CPR)
Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Context: Cardiopulmonary Resuscitation (CPR) guidelines recommend target values for selected CPR parameters related to rate and depth of chest compressions and ventilations, and avoidance of CPR-free intervals. Recent studies on adult patients however show that rescuers often do not adhere to these guidelines. There is currently very little data on the quality of CPR performed on pediatric patients, but given the close similarity in therapy it can be expected that the adherence to Guidelines is suboptimal for this patient group as well. Feedback on quality of chest compressions and ventilations delivered during CPR are most frequently guided by a subjective "code leader", and not objective measurements. Quantitative systems that provide CPR feedback have demonstrated improvement to adult patient treatment. Based on these studies, these feedback systems (termed Quality of CPR or Q-CPR systems) were further improved in a new device called Heartstart MRx with Q-CPR option (MRx/Q-CPR). These devices have been approved by the FDA for use for patients >8 years. The MRX/Q-CPR, attached by a cord to the defibrillator/monitor, detects, displays and records the rate, force and the depth of compressions through an accelerometer and force transducer inside the compression pad. These devices have currently been approved by the CHOP Resuscitation Committee and Medical device committee for clinical implementation in the CHOP Intensive Care units (ICU) and Emergency Department (ED).
Objectives: The goal of this study is to record and analyze the data from the MRx/Q-CPR during in-hospital cardiac arrests of children > 8 years for two research objectives. The primary research objective is to evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. A secondary research objective is to determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Children's Hospital of Philadelphia
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Cardiac Arrest Inclusion Criteria:
- Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
- Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed
Clinical Staff Inclusion Criteria:
- All clinical staff who participate in resuscitation events in CHOP's ICU or ED
Exclusion Criteria:
- Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.
Délai: Ongoing
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Ongoing
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety.
Délai: Ongoing
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Ongoing
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Vinay Nadkarni, MD, Children's Hospital of Philadelphia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2006-6-4839
- 1K23HD062629-01A1 (Subvention/contrat des NIH des États-Unis)
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