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
Thomas Riva
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.
Description
Eligible children will be prepared for intubation according to the local SOPs of the pediatric anesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP. Induction of anesthesia: If feasible, all children included in this protocol will be pre-oxygenated before induction of anesthesia for one minute through face-mask with FiO2 1.0 and flow rates of 6-10L/min. The induction of anesthesia for tracheal intubation will be performed using a combination of sedative/hypnotic drugs, opioids and non-depolarizing muscle relaxant. The following medications will be mandatory as per pro…
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- No
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 adv…
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 PhiladelphiaPhiladelphia, Pennsylvania
- Perth Children's HospitalPerth, Western Australia
- Hospital Municipal Infantil Menino Jesus, Servicos Medicos de AnestesiaSão Paulo, São Paulo
- Dept. Anesthesia, The Hospital for Sick ChildrenToronto, Ontario
- Dept. Anesthesia, Montreal Children's Hospital, McGill University Health CentreMontreal
- Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité UniversitätsmedizinBerlin