Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)

Summary

This study aims to investigate the optimal oxygen flow rate needed during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) using Miller-blade or Macintosh-blade size No. 0 or No. 1 in the operating room or intensive care unit. The investigators hypothesize that the difference between low-flow and high-flow supplemental oxygen is negligible.

Conditions

• Airway Management

Interventions

DEVICE

Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope

0.2 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

DEVICE

High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope

2 L/kg/min FiO2 1.0 high-flow nasal supplemental oxygen (Fisher \& Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Sponsors & Collaborators

• University Hospital, Geneva

  collaborator OTHER

• Kantonsspital Aarau

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Perth Children's Hospital

  collaborator UNKNOWN

• The Hospital for Sick Children

  collaborator OTHER

• Istituto Giannina Gaslini

  collaborator OTHER

• Cantonal Hospital of Lucerne

  collaborator UNKNOWN

• Children's Hospital of Philadelphia

  collaborator OTHER

• Montreal Children's Hospital of the MUHC

  collaborator OTHER

• Thomas Riva

  lead OTHER

Principal Investigators

• Thomas Riva, MD · University of Bern

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

52 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2027-06-30

Completion

2027-09-30

Countries

• United States
• Australia
• Brazil
• Canada
• Germany
• Italy
• Switzerland

Study Locations