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

NCT05967507 | Unknown

• 1 other identifier: OPTIMISE-2-trial
• Study Type: interventional
• Target: 1,192
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  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.

  15 minutes

Secondary Outcomes (10)

• Occurrence of severe desaturation

  15 minutes

• Overall number of intubation attempts

  15 minutes

• First attempt success rate of tracheal intubation

  15 Minutes

• Time required for intubation

  5 minutes

• First EtCO2 after successful intubation

  10 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

0.2 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Device: Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope

Control group

ACTIVE COMPARATOR

2 L/kg/min FiO2 1.0 high-flow nasal supplemental oxygen with the Optiflow (Fisher \& Paykel Healthcare, Auckland, New Zealand) during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Device: High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope

Interventions

Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope 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.

Intervention group

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

Control group

Eligibility Criteria

• Age: Up to 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You 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 may not qualify 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.

Sponsors & Collaborators

• Thomas Riva: lead
• University Hospital, Geneva: collaborator
• Kantonsspital Aarau: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Charite University, Berlin, Germany: collaborator
• Royal Perth Hospital: collaborator
• The Hospital for Sick Children: collaborator
• Istituto Giannina Gaslini: collaborator

Study Sites (6)

Dept. Anesthesia, The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

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

Montreal, Canada

RECRUITING

Deutsches Herzzentrum der Charité and Charité

Berlin, 13353, Germany

RECRUITING

Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin

Berlin, Germany

RECRUITING

Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

Study Officials

• Thomas Riva, MD

  University of Bern

  STUDY CHAIR

Central Study Contacts

Alexander Fuchs, MD

CONTACT

+41 31 632 52 01; alexander.fuchs@insel.ch

Thomas Riva, MD

CONTACT

+41 31 632 17 09; thomasriva@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: December 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); DE (2); CA (2)