What this study is
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.
What's being tested
- Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope
Intervention · DEVICE
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
Intervention · DEVICE
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 details
- Official title
- 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
- Conditions
- Airway Management
- Enrolling
- 1,192 people
- Starts
- 2023-12-01
- Est. completion
- 2027-09
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 52 WeeksSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (11)
10 openChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Annery Garcia Marcinkiewicz, Professor · Contact800-879-2467garciamara@chop.edu
- Annery Garcia Marcinkiewicz, MD · Principal investigator
Recruiting
10 sites outside the US
Perth Children's Hospital
Perth, Western Australia, Australia
- Britta von Ungern Sternberg, Prof · Contact+08 6456 2222britta.regli-vonungern@uwa.edu.au
- Britta von Ungern Sternberg, MD · Principal investigator
RecruitingHospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia
São Paulo, São Paulo, Brazil
- Vinicius Quintao, Prof · Contact+55 11 3016-0500vinicius.quintao@hc.fm.usp.br
- Vinicius Quintao, MD · Principal investigator
RecruitingDept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario, Canada
- Clyde Matava, Prof. · Contactclyde.matava@sickkids.ca
- Clyde Matava, MD · Principal investigator
RecruitingDept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal, Canada
- Thomas Engelhardt, Prof. · Contactthomas.engelhardt@mcgill.ca
- Thomas Engelhardt, MD · Principal investigator
RecruitingDepartment of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin, Germany
- Maren Kleine-Brueggeney, Prof. Dr. · Contactmaren.kleine-brueggeney@dhzc-charite.de
- Maren Kleine-Brueggeney, MD · Principal investigator
RecruitingIRCCS Istituto Giannina Gaslini
Genova, Italy
- Nicola Disma, Prof · Contact+39 010 56361nicoladisma@gaslini.org
- Nicola Disma, MD · Principal investigator
RecruitingKantonsspital Aarau, KSA
Aarau, Canton of Aargau, Switzerland
- Lorenz Theiler, Prof · Contact+41 062 838 41 41lorenz.theiler@ksa.ch
- Lorenz Theiler, MD · Principal investigator
RecruitingLuzerner Kantonsspital
Lucerne, Canton of Lucerne, Switzerland
- Martin Hoelzle, MD · Contact+41 41 205 61 11martin.hoelzle@luks.ch
- Martin Hoelzle, MD · Principal investigator
RecruitingInselspital
Bern, Switzerland
- Alexander Fuchs, MD · Contact41316321709alexander.fuchs@insel.ch
- Thomas Riva, MD · Contact41316321709thomas.riva@insel.ch
- Alexander Fuchs, MD · Principal investigator
RecruitingCHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Active, not recruiting
Study team
Sponsor
Thomas Riva
Study ID OPTIMISE-2-trial
Study chair
Thomas Riva, MD
University of Bern
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.