RecruitingNot ApplicableNCT05967507

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

Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2): a Multi-center, Non-inferiority, Prospective Randomized Controlled Trial


Sponsor

Thomas Riva

Enrollment

1,192 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 52 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope and a medical device called Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope for people with airway management. The study is currently recruiting participants at 11 locations. People eligible for this study include up to age 52 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow-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.

DEVICEHigh-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.


Locations(11)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Perth Children's Hospital

Perth, Western Australia, Australia

Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia

São Paulo, São Paulo, Brazil

Dept. Anesthesia, The Hospital for Sick Children

Toronto, Ontario, Canada

Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre

Montreal, Canada

Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin

Berlin, Germany

IRCCS Istituto Giannina Gaslini

Genova, Italy

Kantonsspital Aarau, KSA

Aarau, Canton of Aargau, Switzerland

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Inselspital

Bern, Switzerland

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05967507


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