Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424678
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent Places
Sponsor:
Sociedad Española de Anestesiología Reanimación y Terapéutica del Dolor
Organization:
Sociedad Española de Anestesiología Reanimación y Terapéutica del Dolor
Study Overview
Official Title:
Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None