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

Not yet recruiting
Conditions
Cardiorespiratory Arrest
Interventions
Other: Only data collection in the Utstein template
Registration Number
NCT06424678
Lead Sponsor
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
200
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
cardiorespiratory arrest in adult patientsOnly data collection in the Utstein templateThe epidemiology of the data collected in the Utstein template will be described in patients who suffer cardiac arrest in the surgical block and are aged from 18 years and 1 day to 11o years.
Cradiorespiratory arrest in paediatric patientsOnly data collection in the Utstein templateThe epidemiology of the data collected in the Utstein template will be described in patients who suffer cardiac arrest in the surgical block and have an age between 1 month and 1 day to 18 years.
Primary Outcome Measures
NameTimeMethod
Survival to discharge from the surgical block will be evaluatedFrom 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 Outcome Measures
NameTimeMethod
Survival to hospital discharge with good neurological statusFrom June 1, 2025 to June 1, 2029

Neurological outcome at 30 days or at hospital discharge if it occurs before that period. Registers as Cerebral Performance Category (CPC), Pediatric CPC (PCPC), or modified Rankin Scale (mRS) score, and can be measured face-to-face, telephone interview, or a combination. The PCC is a 5-point scale ranging from 1 (good brain performance) to 5 (dead). The PCPC is a scale that goes from 1 (good brain performance) to 6 (dead). The mRS is a scale that ranges from 0 (no symptoms) to 6 (dead). Survival with favorable neurological conditions is defined as a CPC of 1 or 2, mRS of 0 to 3, or no change in CPC or mRS with respect to the patient's pre-arrest status. Include a definition of how it was measured (face- to-face, extracted from notes, combination.

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