Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent Places

Официальное название

Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent

Обзор

A protocol for recording cardiopulmonary arrest (CRP) data in the in-hospital surgical block has been designed with the Utstein template model. The database is hosted in accordance with European legislation on patient data protection. Invitation to participate will be sent to Spanish hospitals in the first phase. Once this is over, participation in the registry will be opened to European hospitals. Survival and neurological outcome will be evaluated upon discharge from the surgical block. The study design is a prospective observational registry of a cohort of subjects who have suffered a CRP in the surgical block.

Подробное описание

Patients will be enrolled by participating researchers from Spanish hospitals that have a pediatric surgery service, in addition to surgery on adult patients, who will collect and upload the data into a protected web-based electronic database. The recorded variables are grouped as follows: patient variables, hospital data, data prior to cardiopulmonary arrest (CRP), data from cardiopulmonary arrest (CRP), data after cardiopulmonary resuscitation (CPR), results of cardiopulmonary resuscitation (CPR). For the study, cardiorespiratory arrest (CRP) is defined as cardiac arrest for which resuscitation is attempted with chest compressions, defibrillation, or both. In the pediatric population it may include patients receiving chest compressions for poor perfusion in the setting of severe bradycardia.

The inclusion criteria are: all patients older than 1 month who undergo sedation, anesthesia or monitored anesthetic surveillance performed by an anesthesiologist and suffer cardiorespiratory arrest in the surgical block. Subsequent episodes of cardiorespiratory arrest (CRP) in the same subject may be included. Exclusion criteria: hospitals that do not have a pediatric surgery service in their service portfolio, patients being treated with extracorporeal circulatory support (ECMO, extracorporeal circulation pump or ventricular assistance) at the time of cardiorespiratory arrest. Patients who suffer cardiac arrest and require any type of extracorporeal circulatory support for the recovery of spontaneous circulation after performing the corresponding cardiopulmonary resuscitation (CPR) will not be eliminated.

The data collection period will be valid for 48 months, starting on June 1, 2025 and the last day being June 1, 2029.

Вмешательства

• Другое Only data collection in the Utstein template
  The intervention that we will carry out in both groups will consist of collecting data from the patient (age, sex and race), on cardiopulmonary arrest, cardiopulmonary resuscitation, and the results of cardiopulmonary resuscitation.

Первичные конечные точки

• Survival to discharge from the surgical block will be evaluated [Срок оценки: From June 1, 2025 to June 1, 2029]

Вторичные конечные точки (1)

• Survival to hospital discharge with good neurological status [Срок оценки: From June 1, 2025 to June 1, 2029]

Критерии участия

Inclusion Criteria:Patients over 1 month of age who suffer cardiac arrest in the surgical unit and/or in those places where some type of monitored surveillance technique, sedation and/or anesthesia is performed by an anesthesiologist or internal resident specialist (EIR) of the specialty of Anesthesiology.

Критерии исключения

• Patients with procedures defined as major outpatient surgery in the hospital where the cardiac arrest occurs.
• Patients in supportive treatment extracorporeal circulatory system (ECMO) or ventricular assist at the time of cardiac arrest.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Berg KM, Bray JE, Ng KC, Liley HG, Greif R, Carlson JN, Morley PT, Drennan IR, Smyth M, Scholefield BR, Weiner GM, Cheng A, Djarv T, Abelairas-Gomez C, Acworth J, Andersen LW, Atkins DL, Berry DC, Bhanji F, Bierens J, Bittencourt Couto T, Borra V, Bottiger BW, Bradley RN, Breckwoldt J, Cassan P, Chang WT, Charlton NP, Chung SP, Considine J, Costa-Nobre DT, Couper K, Dainty KN, Dassanayake V, Davis PMID 37937881
• Nolan JP, Berg RA, Andersen LW, Bhanji F, Chan PS, Donnino MW, Lim SH, Ma MH, Nadkarni VM, Starks MA, Perkins GD, Morley PT, Soar J. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Template for In-Hospital Cardiac Arrest: A Consensus Report From a Task Force of the International Liaison Committee on Resuscitation (American Heart Associ PMID 31522544
• Ministerio de Sanidad y política social.Bloque Quirúrgico. Estándares y recomendaciones. Madrid. Centro de publicaciones. 2009.301 p.

Идентификаторы

NCT: NCT06424678 · SeRCP022024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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