- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ankara
-
Ankara, Ankara, Tyrkia (Türkiye), 06230
- Hacettepe University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Chest Compression Rate During Simulated Pediatric CPR
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant-Reported Fatigue
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SBA24-1093 (Annen identifikator: Hacettepe University Health Sciences Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .