Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT

NCT03021122 | Completed

• 1 other identifier: SNSF_32003B_169348
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

Brief Summary

The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.

1. 1.Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
2. 2.Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).

Conditions

Resuscitation; Pediatrics

Keywords

Medication errors; Resuscitation; Drugs; Pediatrics; Biomedical technology

Outcome Measures

Primary Outcomes (1)

• Medication dosage errors

  To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.

  On the day of study participation

Secondary Outcomes (1)

• Time to drug preparation (TDP) and time to drug delivery (TDD)

  On the day of study participation

Study Arms (2)

Arm A (PedAMINES™ / Conventional Method)

EXPERIMENTAL

A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method.

Device: PedAMINES™ / Conventional Method

Arm B (Conventional Method / PedAMINES™)

ACTIVE COMPARATOR

A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™.

Device: Conventional Method / PedAMINES™

Interventions

PedAMINES™ / Conventional Method DEVICE

Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • PedAMINES™ (Period 1) and then Conventional Method (Period 2)

Arm A (PedAMINES™ / Conventional Method)

Conventional Method / PedAMINES™ DEVICE

Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Conventional Method (Period 1) and then PedAMINES™ (Period 2)

Arm B (Conventional Method / PedAMINES™)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be nurse certified
• To know how to prepare intravenous drugs injection.
• To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study.
• Participation agreement

You may not qualify if:

• To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation.
• To have not undergone the 5-minute introductory course to the use of PedAMINES.

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead
• University of Geneva, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Neuchâtel Hospital, Neuchâtel, Switzerland: collaborator
• Fribourg Hospital, Fribourg, Switzerland: collaborator
• Sion Hospital, Sion, Switzerland: collaborator

Study Sites (6)

Hôpital de l'Enfance (HEL)

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Hôpital du Valais

Sion, Valais, 1950, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

HFR Fribourg

Fribourg, 1752, Switzerland

Location

Geneva Children's Hospital, Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Hôpital Neuchâtelois

Neuchâtel, 2000, Switzerland

Location

Related Publications (5)

• Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.

  PMID: 23339874 BACKGROUND

• Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005.

  PMID: 28148473 BACKGROUND

• Siebert JN, Gosetto L, Sauvage M, Bloudeau L, Suppan L, Rodieux F, Haddad K, Hugon F, Gervaix A, Lovis C, Combescure C, Manzano S, Ehrler F; PedAMINES Trial Group; PedAMINES Prehospital Group. Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials. JMIR Hum Factors. 2022 Mar 1;9(1):e35399. doi: 10.2196/35399.

  PMID: 35230243 DERIVED

• Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.

  PMID: 30797722 DERIVED

• Siebert JN, Ehrler F, Lovis C, Combescure C, Haddad K, Gervaix A, Manzano S. A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial. JMIR Res Protoc. 2017 Aug 22;6(8):e167. doi: 10.2196/resprot.7901.

  PMID: 28830854 DERIVED

Study Officials

• Johan N Siebert, MD

  Geneva Children Hospital, Geneva University Hospitals, Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding to the purpose of the study during recruitment will be maintained to minimize preparation bias. Nurses will be "unblinded" when the simulated scenario start.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD: Emergency Physician

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 13, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

CH (6)