Cardio Respiratory ArrestNCT06300710
Outcomes and Risk Factors of CPR in PICU
An observational study of Cardio Respiratory Arrest, run by Assiut University.
Trial summary
1. To detect the frequency and the underlying causes of cardiopulmonary arrest . 2. To detect outcome of CPR 3. To identify the associated risk factors for the different outcomes after CPR among those patients Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardio Respiratory Arrest
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged from 1 month to 18 years who suffered in-PICU CA between March 2024 to February 2025 will be included. Cardiopulmonary arrest was defined as the presence of unresponsiveness, apnea, absence of signs of life, and absence of a palpable central pulse or bradycardia of <60 bpm with poor perfusion in infants, requiring external cardiac compressions and assisted ventilation
Who may be able to join
- Including Children aged 1 month to 18 years who received at least 1 minute of CPR
Who cannot join
- Exclusion of 1-Children aged below1 month and older than 18 years .
- terminal disease patients, such as malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome of Cardiopulmonary Resuscitation in Tertiary Level PICU and Associated Risk Factors
- To detect the frequency and the underlying causes of cardiopulmonary arrest .
- To detect outcome of CPR
- To identify the associated risk factors for the different outcomes after CPR among those patients
Read the detailed description
Cardiac arrest (CA) is uncommon in children, and the epidemiology of pediatric CA is different from adults. CA Is a critical cause of death in children in the hospital especially in the pediatric Intensive care unit (PICU). CA Is reported in 2-6% of children in the PICU, which is much higher than out-of-hospital arrest (about 8 to 20 annual cases per 100,000 pediatric population .
Previous studies reported that return of spontaneous circulation (ROSC) after cardiopulmonary Resuscitation (CPR) for in-hospital CA (IHCA) is about half of these patients, and ∼30% survived to hospital discharge Previous studies had analyzed the cause and prognostic factors associated with outcomes after IHCA, which included the Initial rhythm, duration of CA and CPR, the underlying disease, and where the event attacked .
Patients in PICU are more likely to develop CA because they are more critically ill. Information on factors associated with prognosis of in-PICU CA can promote Improvement in PICU care, which means improving survival with good neurologic outcomes .
Analyzing the epidemiological variables and risk/prognostic factors of in-PICU CA is of great Importance in developing the better therapeutic strategy and deciding appropriate preventive Measure .
Probability of death on admission and a longer length Of stay in the PICU were associated with increased odds of receiving CPR. Children admitted with cardiac conditions were at significantly higher risk of receiving CPR in the PICU Compared with those Admitted with noncardiac primary diagnosis. The risk Of receiving CPR was significantly associated with age, History of preadmission CPR, also, Electrolyte Imbalances and Multi-organ Dysfunction increase risk of receiving CPR in PICU .
- Conditions
- Cardio Respiratory Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive)
(dead versus alive)
Measured: 1 year
Secondary outcomes (1)
Rate of risk factors associated with outcome of CPR
Rate of the risk factors associated with the outcome of CPR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardio Respiratory ArrestStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hamed Khalaf Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300710
- Sponsor's protocol ID
- CPR in PICU
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee EP, Chan OW, Lin JJ, Hsia SH, Wu HP. Risk Factors and Neurologic Outcomes Associated With Resuscitation in the Pediatric Intensive Care Unit. Front Pediatr. 2022 Apr 4;10:834746. doi: 10.3389/fped.2022.834746. eCollection 2022.
PubMed 35444968Choi J, Choi AY, Park E, Moon S, Son MH, Cho J. Trends in Incidences and Survival Rates in Pediatric In-Hospital Cardiopulmonary Resuscitation: A Korean Population-Based Study. J Am Heart Assoc. 2023 Feb 7;12(3):e028171. doi: 10.1161/JAHA.122.028171. Epub 2023 Jan 25.
PubMed 36695322Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Huei-Ming Ma M, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Eng Hock Ong M, Travers AH, Nolan JP; Utstein Collaborators. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals 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); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Circulation. 2015 Sep 29;132(13):1286-300. doi: 10.1161/CIR.0000000000000144. Epub 2014 Nov 11.
PubMed 25391522Kuisma M, Suominen P, Korpela R. Paediatric out-of-hospital cardiac arrests--epidemiology and outcome. Resuscitation. 1995 Oct;30(2):141-50. doi: 10.1016/0300-9572(95)00888-z.
PubMed 8560103Reis AG, Nadkarni V, Perondi MB, Grisi S, Berg RA. A prospective investigation into the epidemiology of in-hospital pediatric cardiopulmonary resuscitation using the international Utstein reporting style. Pediatrics. 2002 Feb;109(2):200-9. doi: 10.1542/peds.109.2.200.
PubMed 11826196
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Cardiopulmonary Resuscitation in Tertiary Level PICU and Associated Risk Factors
- ClinicalTrials.gov ID
- NCT06300710
- Acronym / sponsor ID
- CPR in PICU
- Conditions
- Cardio Respiratory Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Mar 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.
- To detect the frequency and the underlying causes of cardiopulmonary arrest .
- To detect outcome of CPR
- To identify the associated risk factors for the different outcomes after CPR among those patients
Detailed description
Cardiac arrest (CA) is uncommon in children, and the epidemiology of pediatric CA is different from adults. CA Is a critical cause of death in children in the hospital especially in the pediatric Intensive care unit (PICU). CA Is reported in 2-6% of children in the PICU, which is much higher than out-of-hospital arrest (about 8 to 20 annual cases per 100,000 pediatric population .
Previous studies reported that return of spontaneous circulation (ROSC) after cardiopulmonary Resuscitation (CPR) for in-hospital CA (IHCA) is about half of these patients, and ∼30% survived to hospital discharge Previous studies had analyzed the cause and prognostic factors associated with outcomes after IHCA, which included the Initial rhythm, duration of CA and CPR, the underlying disease, and where the event attacked .
Patients in PICU are more likely to develop CA because they are more critically ill. Information on factors associated with prognosis of in-PICU CA can promote Improvement in PICU care, which means improving survival with good neurologic outcomes .
Analyzing the epidemiological variables and risk/prognostic factors of in-PICU CA is of great Importance in developing the better therapeutic strategy and deciding appropriate preventive Measure .
Probability of death on admission and a longer length Of stay in the PICU were associated with increased odds of receiving CPR. Children admitted with cardiac conditions were at significantly higher risk of receiving CPR in the PICU Compared with those Admitted with noncardiac primary diagnosis. The risk Of receiving CPR was significantly associated with age, History of preadmission CPR, also, Electrolyte Imbalances and Multi-organ Dysfunction increase risk of receiving CPR in PICU .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged from 1 month to 18 years who suffered in-PICU CA between March 2024 to February 2025 will be included. Cardiopulmonary arrest was defined as the presence of unresponsiveness, apnea, absence of signs of life, and absence of a palpable central pulse or bradycardia of <60 bpm with poor perfusion in infants, requiring external cardiac compressions and assisted ventilation
Key inclusion criteria (1 listed)
- Including Children aged 1 month to 18 years who received at least 1 minute of CPR
Key exclusion criteria (2 listed)
- Exclusion of 1-Children aged below1 month and older than 18 years .
- terminal disease patients, such as malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive)
Time frame: 1 year
(dead versus alive)
1 secondary outcome
Rate of risk factors associated with outcome of CPR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 35444968Lee EP, Chan OW, Lin JJ, Hsia SH, Wu HP. Risk Factors and Neurologic Outcomes Associated With Resuscitation in the Pediatric Intensive Care Unit. Front Pediatr. 2022 Apr 4;10:834746. doi: 10.3389/fped.2022.834746. eCollection 2022.
- Background: PubMed 36695322Choi J, Choi AY, Park E, Moon S, Son MH, Cho J. Trends in Incidences and Survival Rates in Pediatric In-Hospital Cardiopulmonary Resuscitation: A Korean Population-Based Study. J Am Heart Assoc. 2023 Feb 7;12(3):e028171. doi: 10.1161/JAHA.122.028171. Epub 2023 Jan 25.
- Background: PubMed 25391522Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Huei-Ming Ma M, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Eng Hock Ong M, Travers AH, Nolan JP; Utstein Collaborators. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals 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); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Circulation. 2015 Sep 29;132(13):1286-300. doi: 10.1161/CIR.0000000000000144. Epub 2014 Nov 11.
- Background: PubMed 8560103Kuisma M, Suominen P, Korpela R. Paediatric out-of-hospital cardiac arrests--epidemiology and outcome. Resuscitation. 1995 Oct;30(2):141-50. doi: 10.1016/0300-9572(95)00888-z.
- Background: PubMed 11826196Reis AG, Nadkarni V, Perondi MB, Grisi S, Berg RA. A prospective investigation into the epidemiology of in-hospital pediatric cardiopulmonary resuscitation using the international Utstein reporting style. Pediatrics. 2002 Feb;109(2):200-9. doi: 10.1542/peds.109.2.200.
Related trials for Cardio Respiratory Arrest
RecruitingObservational study
Quality of Pediatric Resuscitation in a Multicenter Collaborative
Cardiac Arrest, Cardiopulmonary Arrest
Active, not recruitingObservational study
Carotid Ultrasound Under Pulsed-wave Doppler Mode to Check the Pulse in Cardiopulmonary Arrest Patients.
Cardiac Arrest
Recruiting
COMPARE-VENT Feasibility Pilot Study
Respiration Failure, Cardio Vascular Disease
Recruiting
Simulation Trial of Telemedical Support for Paramedics
Emergencies, Cardiopulmonary Arrest
RecruitingObservational study
AiCR : Artificial Intelligence in Cardiac aRrest
Cardio Respiratory Arrest
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio Respiratory Arrest, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman HK Khalaf, Resident physician (+201111452811, emanh.khalaf1911@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive) (time frame: 1 year). 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 NCT06300710, which also lists 5 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 30 Jul 2024.