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Effect of IAM With an I-gel® on Ventilation Parameters in Simulated Pediatric OHCA

NCT05498402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-09-18

No results posted yet for this study

Summary

Pediatric cardiac arrest occurs most in the prehospital setting. Most of them are due to respiratory failure (e.g., trauma, drowning, respiratory distress), where hypoxia leads to cardiac arrest. Generally, emergency medical services (EMS) first use basic airway management techniques i.e., the use of a bag-valve-mask (BVM) device, to restore oxygenation in pediatric OHCA victims. However, these devices present many drawbacks and limitations. Intermediate airway management, i.e., the use of SGA devices, especially the i-gel® has several advantages. It has been shown to enhance both circulatory and ventilatory parameters. There is increasing evidence that IAM devices can safely be used in children. In two pediatric studies of OHCA, American paramedics had significantly higher success rates with SGA devices than with TI. A neonatal animal model showed that the use of SGA was feasible and non-inferior to TI in this population. However, data regarding the effect of IAM with an i-gel® versus the use of a BVM on ventilation parameters during pediatric OHCA is missing. The hypothesis underlying this study is that, in case of pediatric OHCA, early insertion of an i-gel® device without prior BVM ventilation should improve ventilation parameters in comparison with the standard approach consisting in BVM ventilations.

Conditions

  • Pediatric ALL
  • Cardiac Arrest
  • Cardiopulmonary Arrest
  • Resuscitation
  • Pediatric Emergency Medicine

Interventions

DEVICE

i-gel ® device

Ventilations will be delivered through an i-gel ® device

DEVICE

bag-valve-mask ventilation

Ventilations will be delivered using a bag-valve-mask

Sponsors & Collaborators

  • ESAMB - College of Higher Education in Ambulance Care

    collaborator UNKNOWN

  • Ambulances de la Ville de Sion

    collaborator UNKNOWN

  • University Hospital, Geneva

    collaborator OTHER

  • Geneve TEAM Ambulances

    lead OTHER

Principal Investigators

  • Loric Stuby · Genève TEAM Ambulances

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-06-13
Completion
2023-06-13

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498402 on ClinicalTrials.gov