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Clinical Trials/NCT06424678
NCT06424678
Not yet recruiting
Not Applicable

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

Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor0 sites200 target enrollmentJune 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiorespiratory Arrest
Sponsor
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
Enrollment
200
Primary Endpoint
Survival to discharge from the surgical block will be evaluated
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2025
End Date
June 1, 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
Responsible Party
Principal Investigator
Principal Investigator

Maria Concepcion Ruiz-Villen

Doctor (PhD) in Medicine and Surgery. Faculty specialist in Anaesthesiology, Intensive Care and Pain

Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

Eligibility Criteria

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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Survival to discharge from the surgical block will be evaluated

Time Frame: From June 1, 2025 to June 1, 2029

We define survival upon discharge from the BQ as that patient with recovery of spontaneous circulation after cardiac arrest, who is discharged with signs of life to the hospital ward.

Secondary Outcomes

  • Survival to hospital discharge with good neurological status(From June 1, 2025 to June 1, 2029)

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