Recruiting

C-MAC

Sponsor:

Thomas Riva

Code:

NCT05967507

Conditions

Airway Management

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT05967507

Start date

Dec 1, 2023

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

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.

active comparator: Control group

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.

Interventions

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.

Primary outcome measure

  • First attempt success rate [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Alexander Fuchs, MD

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

Thomas Riva, MD

+41 31 632 17 09thomasriva@me.com

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Annery Garcia Marcinkiewicz, Professor

800-879-2467garciamara@chop.edu

Principal Investigator:

Annery Garcia Marcinkiewicz, MD

Dept. Anesthesia, The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Clyde Matava, Prof.

clyde.matava@sickkids.ca

Principal Investigator:

Clyde Matava, MD

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

Recruiting

Montreal, Canada

Contacts

Thomas Engelhardt, Prof.

thomas.engelhardt@mcgill.ca

Principal Investigator:

Thomas Engelhardt, MD

More Information

Sponsor

Thomas Riva

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Riva on 2026-05-12.