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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 52
SponsorThomas Riva

About this trial

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.

Eligibility criteria

Qualifiers

Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical indications.

Neonates and infants up to 52 weeks postconceptual age, with legal guardians providing written informed consent before the intervention

Disqualifiers

Prediction of difficult intubation upon physical examination or previous history of difficult intubation, mandating a technique different than direct laryngoscopy to secure the airway;

Congenital heart disease demanding FiO2 < 1.0

Cardiopulmonary collapse requiring advanced life support

Intubation for emergency surgical and non-surgical indications.

Trial design

Treatments tested in this trial

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

Treatment groups

1,192 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Thomas Riva

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Sponsor institution

University Hospital, Geneva

Collaborator

Kantonsspital Aarau

Collaborator

Centre Hospitalier Universitaire Vaudois

Collaborator

Charite University, Berlin, Germany

Collaborator

Perth Children's Hospital

Collaborator

The Hospital for Sick Children

Collaborator

Istituto Giannina Gaslini

Collaborator

Cantonal Hospital of Lucerne

Collaborator

Children's Hospital of Philadelphia

Collaborator

Montreal Children's Hospital of the MUHC

Collaborator