Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness

NCT04464603 | Not Yet Recruiting

• 1 other identifier: InterFACE
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary pediatric physicians and nurses. The impact of a mHealth supportive tool will be compared with conventional communication methods on situational awareness, leadership, team communication effectiveness and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The primary endpoint is the situational awareness score measured with the situation awareness global assessment technique (SAGAT) instrument.

Conditions

Cardiopulmonary Arrest; Pediatric ALL; Resuscitation

Keywords

Information technologies; Situation Awareness; Teamwork; Leadership; Mobile applications; Biomedical Technology

Outcome Measures

Primary Outcomes (1)

• Situational awareness

  Situational awareness (SA) will be measured using retrospective video review by the SA global assessment technique (SAGAT) instrument for each scenario, both as the score of each SAGAT at an individual level and at the team level (given as the sum of individual SAGAT scores for each team; TSAGAT). The SAGAT responses for categorical variables will be scored as either correct (1) or incorrect (0) by two of the investigators, irrespective of whether they agreed completely with the true answer. For numerical responses, answers will be considered correct based upon a 10% pre-defined tolerance range settled by the research investigators around the true value. The scores will be expressed as percentages in conjunction with absolute n/N values. Higher SA scores will denote higher SA.

  40 minutes

Secondary Outcomes (7)

• Resuscitation team leader evaluation

  40 minutes

• Team Emergency Assessment Measure

  40 minutes

• Medication dosage errors

  40 minutes

• Time to critical life-saving maneuvers

  40 minutes

• System usability scale

  10 minutes

Study Arms (2)

Arm A (InterFACE)

EXPERIMENTAL

Participants that will use the mHeath InterFACE tool during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).

Device: InterFACE (mHealth tool)

Arm B (Conventional methods)

ACTIVE COMPARATOR

Participants that will use conventional methods during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).

Other: Conventional methods

Interventions

InterFACE (mHealth tool) DEVICE

Participants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin. Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines. Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills. Participants allocated to Arm A will not be allowed to use any other cognitive support.

Arm A (InterFACE)

Conventional methods OTHER

Participants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin. Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines. Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills. Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool.

Arm B (Conventional methods)

Eligibility Criteria

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

You may qualify if:

• Any physician performing a fellowship in the pediatric emergency department.
• Any postgraduate residents pursuing a \<5 years residency in pediatrics.
• To be registered nurses from the PED.
• To have previously completed a standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.
• Participation agreement

You may not qualify if:

• To have not undergone the standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Geneva Children's Hospital, Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (2)

• Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.

  PMID: 32292179 BACKGROUND

• Ehrler F, Sahyoun C, Manzano S, Sanchez O, Gervaix A, Lovis C, Courvoisier DS, Lacroix L, Siebert JN. Impact of a shared decision-making mHealth tool on caregivers' team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial. Trials. 2021 Apr 13;22(1):277. doi: 10.1186/s13063-021-05170-3.

  PMID: 33849611 DERIVED

MeSH Terms

Conditions

Heart Arrest; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Johan N Siebert, MD

  Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan N Siebert, MD

CONTACT

+41 79 553 40 72; Johan.Siebert@hcuge.ch

Frederic Ehrler, PhD

CONTACT

Frederic.Ehrler@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding to the outcomes will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and will not be released until the participants start the scenario. A post-scenario video review will be done without blinding by two reviewers, but undertaken independently with each blinded to the other's reviews. In the case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Deputy Head

Model Details: A prospective, single center, randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 9, 2020
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available from 1 month to 10 years after trial publication.
• Access Criteria: From the corresponding author upon reasonable request.

Locations

CH (1)