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

NCT05967507 · tracked via the Priya Life Science Germany tracker

Sponsor

Thomas Riva

Phase

Not applicable

Started

2023-12-01

Last updated

2026-05-12

Condition(s) studied

Airway Management

Investigational drug(s) / intervention(s)

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

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

52 Weeks

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

First attempt success rate — 15 minutes
The primary study outcome is to evaluate the first attempt success rate of oral and nasal tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with supplemental oxygen with low-flow vs high flow among neonates and infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs.

Trial sites (11)

Facility	City	Region	Status
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
Perth Children's Hospital	Perth	Western Australia	Recruiting
Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia	São Paulo	São Paulo	Recruiting
Dept. Anesthesia, The Hospital for Sick Children	Toronto	Ontario	Recruiting
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre	Montreal	Canada	Recruiting
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin	Berlin	Germany	Recruiting
IRCCS Istituto Giannina Gaslini	Genova	Italy	Recruiting
Kantonsspital Aarau, KSA	Aarau	Canton of Aargau	Recruiting
Luzerner Kantonsspital	Lucerne	Canton of Lucerne	Recruiting
Inselspital	Bern	Switzerland	Recruiting
CHUV Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	Active Not Recruiting

More Thomas Riva trials in Germany

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation Recruiting

Other trials for the same condition

External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation Recruiting

Data-driven Development of a Core Dataset for Difficult Airway Alerts Active, not recruiting

Validation of the POGO Score for Classification of Videolaryngoscopy in Children - Post-hoc Analysis of the PeDiAC Study Active, not recruiting

I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation Recruiting

Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05967507 on ClinicalTrials.gov ↗ ← All trials in Germany