- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07624851
One-Minute Versus Two-Minute Compressor Rotation During Simulated Pediatric CPR (CPR-ROT)
One-Minute Versus Two-Minute Compressor Rotation During Simulated Pediatric CPR: A Randomized Crossover Pilot Study
The goal of this clinical trial is to compare one-minute and two-minute compressor rotation intervals during simulated pediatric cardiopulmonary resuscitation, also called CPR. The study will include healthcare professionals who perform chest compressions on a pediatric manikin in a simulated resuscitation setting.
The main questions this study aims to answer are:
Does one-minute compressor rotation improve chest compression quality compared with two-minute compressor rotation? Does one-minute compressor rotation reduce participant fatigue compared with two-minute compressor rotation?
Participants will perform chest compressions during two simulated pediatric CPR sessions. In one session, compressors will rotate every one minute. In the other session, compressors will rotate every two minutes. Researchers will compare CPR performance measures and participant-reported fatigue between the two rotation intervals.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized crossover pilot study evaluates two different compressor rotation intervals during simulated pediatric cardiopulmonary resuscitation. The study is conducted in a simulation setting using a pediatric manikin. No patients are involved, and no clinical care is delivered.
Participants are healthcare professionals trained in pediatric resuscitation. Each participant pair completes two CPR scenarios. In one scenario, chest compressors rotate every one minute. In the other scenario, chest compressors rotate every two minutes. The order of the two scenarios is randomized.
The study compares objective CPR performance metrics obtained during the simulation, including measures related to chest compression quality. It also evaluates participant-reported fatigue after each scenario. Because each pair completes both rotation strategies, the crossover design allows comparison of the two approaches within the same participant pair.
The purpose of this pilot study is to explore whether a shorter compressor rotation interval may help maintain CPR quality or reduce fatigue during simulated pediatric CPR. The findings may help guide future simulation-based research and training strategies for pediatric resuscitation teams.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ankara
-
Ankara, Ankara, Turquía (Türkiye), 06230
- Hacettepe University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Volunteer pediatric residents
- Previous cardiopulmonary resuscitation training
- Prior clinical cardiopulmonary resuscitation experience
- Ability to participate in both simulated pediatric CPR sessions
- Written informed consent provided before study participation
Exclusion Criteria:
- No previous Pediatric Advanced Life Support course attendance
- No prior clinical cardiopulmonary resuscitation experience
- Currently rotating in the pediatric emergency department or pediatric ward during the study period
- Emergency medicine residents
- Presence of a chronic medical condition that could affect physical performance during chest compressions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: One-Minute Then Two-Minute Rotation Sequence
Participants in this arm first performed simulated pediatric CPR with compressor rotation every one minute.
After a rest period, they performed a second simulated pediatric CPR session with compressor rotation every two minutes.
|
During simulated pediatric cardiopulmonary resuscitation, chest compressors rotated every one minute.
Participants performed chest compressions on a pediatric manikin, and CPR performance metrics were recorded during the simulation.
During simulated pediatric cardiopulmonary resuscitation, chest compressors rotated every two minutes.
Participants performed chest compressions on a pediatric manikin, and CPR performance metrics were recorded during the simulation.
|
|
Experimental: Two-Minute Then One-Minute Rotation Sequence
Participants in this arm first performed simulated pediatric CPR with compressor rotation every two minutes.
After a rest period, they performed a second simulated pediatric CPR session with compressor rotation every one minute.
|
During simulated pediatric cardiopulmonary resuscitation, chest compressors rotated every one minute.
Participants performed chest compressions on a pediatric manikin, and CPR performance metrics were recorded during the simulation.
During simulated pediatric cardiopulmonary resuscitation, chest compressors rotated every two minutes.
Participants performed chest compressions on a pediatric manikin, and CPR performance metrics were recorded during the simulation.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Chest Compression Rate During Simulated Pediatric CPR
Periodo de tiempo: From 0 to 20 minutes after the start of each simulated CPR session
|
Chest compression rate was recorded using a manikin-based CPR feedback device during each 20-minute simulated pediatric CPR session.
The rate was compared between the one-minute and two-minute compressor rotation conditions.
|
From 0 to 20 minutes after the start of each simulated CPR session
|
|
Chest Recoil Velocity During Simulated Pediatric CPR
Periodo de tiempo: From 0 to 20 minutes after the start of each simulated CPR session
|
Chest recoil velocity was recorded using a manikin-based CPR feedback device during each 20-minute simulated pediatric CPR session and compared between the one-minute and two-minute compressor rotation conditions.
|
From 0 to 20 minutes after the start of each simulated CPR session
|
|
Proportion of Adequate Chest Compressions
Periodo de tiempo: From 0 to 20 minutes after the start of each simulated CPR session
|
The proportion of adequate chest compressions was defined as the proportion of compressions meeting the pre-specified rate and depth targets.
Adequate compressions were defined as compressions delivered at a rate of 100 to 120 compressions per minute and a target depth of at least 5 cm
|
From 0 to 20 minutes after the start of each simulated CPR session
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant-Reported Fatigue
Periodo de tiempo: At 4, 8, 12, 16, and 20 minutes after the start of each simulated CPR session
|
Participant fatigue was assessed using a 10-point Likert-type fatigue scale.
Scores range from 1 to 10, with 1 indicating the least fatigue and 10 indicating the most fatigue.
Higher scores indicate worse fatigue.
Fatigue scores were compared between the one-minute and two-minute compressor rotation conditions.
|
At 4, 8, 12, 16, and 20 minutes after the start of each simulated CPR session
|
|
Blood Pressure Response Before and After Simulated Pediatric CPR
Periodo de tiempo: At baseline and immediately after completion of each simulated CPR session
|
Systolic and diastolic blood pressure were measured at baseline and at the end of each 20-minute simulated CPR session.
Blood pressure responses were compared between the one-minute and two-minute compressor rotation conditions.
|
At baseline and immediately after completion of each simulated CPR session
|
|
Heart Rate Response During Simulated Pediatric CPR
Periodo de tiempo: At baseline and at 4, 8, 12, 16, and 20 minutes after the start of each simulated CPR session
|
Participant heart rate was measured in beats per minute (bpm) using a standard monitor.
Heart rate values were compared between the one-minute and two-minute compressor rotation conditions.
|
At baseline and at 4, 8, 12, 16, and 20 minutes after the start of each simulated CPR session
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Topjian AA, Raymond TT, Atkins D, Chan M, Duff JP, Joyner BL Jr, Lasa JJ, Lavonas EJ, Levy A, Mahgoub M, Meckler GD, Roberts KE, Sutton RM, Schexnayder SM; Pediatric Basic and Advanced Life Support Collaborators. Part 4: Pediatric Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S469-S523. doi: 10.1161/CIR.0000000000000901. Epub 2020 Oct 21. No abstract available.
- Sawee C, Churuangsuk C, Vattanavanit V. Effect of Compression Rotation Intervals on Cardiopulmonary Resuscitation Quality: A Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2025 Jun 25;13(1):e58. doi: 10.22037/aaemj.v13i1.2704. eCollection 2025.
- Kim DH, Seo YW, Jang TC. CPR quality with rotation of every 1 versus 2 minutes as characteristics of rescuers: A randomized crossover simulation study. Medicine (Baltimore). 2023 Mar 10;102(10):e33066. doi: 10.1097/MD.0000000000033066.
- Pechaksorn N, Vattanavanit V. CPR Compression Rotation Every One Minute Versus Two Minutes: A Randomized Cross-Over Manikin Study. Emerg Med Int. 2020 Sep 1;2020:5479209. doi: 10.1155/2020/5479209. eCollection 2020.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBA24-1093 (Otro identificador: Hacettepe University Health Sciences Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .