NCT06424678

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Jun 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jun 2025Jun 2029

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Expected
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

May 16, 2024

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival to discharge from the surgical block will be evaluated

    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.

    From June 1, 2025 to June 1, 2029

Secondary Outcomes (1)

  • Survival to hospital discharge with good neurological status

    From June 1, 2025 to June 1, 2029

Study Arms (2)

Cradiorespiratory arrest in paediatric patients

The 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.

Other: Only data collection in the Utstein template

cardiorespiratory arrest in adult patients

The 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.

Other: Only data collection in the Utstein template

Interventions

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.

Cradiorespiratory arrest in paediatric patientscardiorespiratory arrest in adult patients

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 1 month of age who suffer cardiac arrest in the surgical block (BQ). Cardiac arrest is defined by the application of chest compressions and/or defibrillation. In the pediatric population it may include patients receiving chest compressions for poor perfusion in the setting of severe bradycardia. We define BQ as "the space in which all the operating rooms are grouped, with the equipment and characteristics necessary to carry out all the planned surgical procedures. The BQ includes the premises where the care process of the surgical procedure takes place (operating room and post-anesthesia recovery unit) and the support premises it requires. In these locations we include the pre-operating room where patients wait, within the surgical block, to enter the operating room.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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 PG, Dawson JA, Fernanda de Almeida M, De Caen AR, Deakin CD, Dicker B, Douma MJ, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Fijacko N, Finn JC, Flores GE, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hatanaka T, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Daripa Kawakami M, Kim HS, Kleinman ME, Kloeck DA, Kudenchuk P, Kule A, Kurosawa H, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin Y, Lockey AS, Macneil F, Maconochie IK, John Madar R, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Monnelly V, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, Ohshimo S, Olasveengen TM, Gene Ong YK, Orkin AM, Parr MJ, Patocka C, Perkins GD, Perlman JM, Rabi Y, Raitt J, Ramachandran S, Ramaswamy VV, Raymond TT, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Singletary EM, Skrifvars MB, Smith CM, Soar J, Stassen W, Sugiura T, Tijssen JA, Topjian AA, Trevisanuto D, Vaillancourt C, Wyckoff MH, Wyllie JP, Yang CW, Yeung J, Zelop CM, Zideman DA, Nolan JP; ; and Collaborators. 2023 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Resuscitation. 2024 Feb;195:109992. doi: 10.1016/j.resuscitation.2023.109992. Epub 2023 Nov 9.

    PMID: 37937881BACKGROUND
  • 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 Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia). Circulation. 2019 Oct 29;140(18):e746-e757. doi: 10.1161/CIR.0000000000000710. Epub 2019 Sep 16.

    PMID: 31522544BACKGROUND
  • Ministerio de Sanidad y política social.Bloque Quirúrgico. Estándares y recomendaciones. Madrid. Centro de publicaciones. 2009.301 p.

    BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • María Conepción Ruiz-Villén

    Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Concepción Ruiz-Villen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (PhD) in Medicine and Surgery. Faculty specialist in Anaesthesiology, Intensive Care and Pain

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

June 1, 2025

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2029

Last Updated

May 22, 2024

Record last verified: 2024-05