Cardiorespiratory ArrestNCT06424678
Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent Places
An observational study of Cardiorespiratory Arrest, run by Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Cardiorespiratory Arrest
- What is being tested?
- Only data collection in the Utstein template
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2029
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent
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.
Read the 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.
- Conditions
- Cardiorespiratory Arrest
- Being tested
- Only data collection in the Utstein template
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only data collection in the Utstein templateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Only data collection in the Utstein template |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From June 1, 2025 to June 1, 2029
Secondary outcomes (1)
Survival to hospital discharge with good neurological status
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.
Measured: From June 1, 2025 to June 1, 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Concepcion Ruiz-Villen, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
- Investigators
- María Conepción Ruiz-Villén, Principal investigator, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424678
- Sponsor's protocol ID
- SeRCP022024
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected in the Utstein template can be shared with other SEDAR researchers. The data will be encrypted.
Publications
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.
PubMed 37937881Nolan 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.
PubMed 31522544Ministerio de Sanidad y política social.Bloque Quirúrgico. Estándares y recomendaciones. Madrid. Centro de publicaciones. 2009.301 p.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent
- ClinicalTrials.gov ID
- NCT06424678
- Acronym / sponsor ID
- SeRCP022024
- Conditions
- Cardiorespiratory Arrest
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sociedad Española de Anestesiología, Reanimación y Terapéutica del DolorUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cradiorespiratory arrest in paediatric patients | – | Other: Only 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. |
| cardiorespiratory arrest in adult patients | – | Other: Only 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. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only data collection in the Utstein templateThe 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. | Other | Cradiorespiratory arrest in paediatric patients, cardiorespiratory arrest in adult patients |
Primary outcome
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.
1 secondary outcome
Survival to hospital discharge with good neurological status
Time frame: From June 1, 2025 to June 1, 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 37937881Berg 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.
- Background: PubMed 31522544Nolan 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.
- BackgroundMinisterio de Sanidad y política social.Bloque Quirúrgico. Estándares y recomendaciones. Madrid. Centro de publicaciones. 2009.301 p.
- Individual participant dataSharing planned: Undecided. Data collected in the Utstein template can be shared with other SEDAR researchers. The data will be encrypted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Conepción Ruiz-Villén principal investigator
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiorespiratory Arrest, run by Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Concepción Ruiz-Villen (+34670601969, concha192010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to discharge from the surgical block will be evaluated (time frame: From June 1, 2025 to June 1, 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424678, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.