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

NCT05498402 | Completed

• 1 other identifier: CPR-6
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Alveolar ventilation per minute

  It will be determined by subtracting the dead space volume from each ventilation, then multiplied by the ventilations' count, and divided by the duration of the ventilation period (i.e., 10 minutes - time to the first ventilation). The simulated child's dead space volume corresponds to about 27 ml using the formula proposed by Numa and Newth. The physiological tidal volume range is of 5 to 8 ml/kg, corresponding to 45 to 72 ml for the simulated child's.

  10 minutes of scenario

Secondary Outcomes (11)

• The proportion, and number of ventilations below, within and over the target volume

  10 minutes of scenario

• The time to the first efficient ventilation

  10 minutes of scenario

• The time to the first compression

  10 minutes of scenario

• The chest compression fraction

  10 minutes of scenario

• The chest compression rate

  10 minutes of scenario

Study Arms (2)

Bag-valve-mask ventilation

ACTIVE COMPARATOR

Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using a bag-valve-mask

Device: bag-valve-mask ventilation

Supraglottic airway device ventilation

EXPERIMENTAL

Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using an i-gel® supraglottic airway device

Device: i-gel ® device

Interventions

i-gel ® device DEVICE

Ventilations will be delivered through an i-gel ® device

Supraglottic airway device ventilation

bag-valve-mask ventilation DEVICE

Ventilations will be delivered using a bag-valve-mask

Bag-valve-mask ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a registered EMT, or paramedic

You may not qualify if:

• Member of the study team

Sponsors & Collaborators

• Geneve TEAM Ambulances: lead
• ESAMB - College of Higher Education in Ambulance Care: collaborator
• Ambulances de la Ville de Sion: collaborator
• University Hospital, Geneva: collaborator

Study Sites (4)

ACE Genève Ambulances

Chêne-Bougeries, Canton of Geneva, 1224, Switzerland

Location

Ambulances de la Ville de Sion

Sion, Valais, 1950, Switzerland

Location

Genève TEAM Ambulances

Geneva, 1201, Switzerland

Location

SK Ambulances

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Stuby L, Bourgeois L, Tinembart JM, Muhlemann E, Thurre D, Siebert JN, Suppan L. Effect of intermediate airway management on ventilation parameters in simulated paediatric out-of-hospital cardiac arrest: a multicentre randomised crossover trial. Swiss Med Wkly. 2025 May 16;155:4079. doi: 10.57187/s.4079.

  PMID: 40450752 DERIVED

Related Links

• Whole project website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Heart Arrest

Condition Hierarchy (Ancestors)

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

Study Officials

• Loric Stuby

  Genève TEAM Ambulances

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, multicenter, crossover, simulation-based, randomized controlled trial

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: January 30, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We plan to submit the protocol for publication in the second semester of 2022. The study's data will be accessible once the results submitted for publication
• Access Criteria: The data would be accessible freely on Yareta

Locations

CH (4)