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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,192

participants targeted

Target at P75+ for not_applicable

Timeline

14mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach

7 countries

11 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress71%

Dec 2023Sep 2027

First Submitted

Initial submission to the registry

July 19, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

July 19, 2023

Last Update Submit

May 9, 2026

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
+5 more secondary outcomes

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 laryngoscopeDEVICE

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 laryngoscopeDEVICE

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

AgeUp to 52 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Contact the study team to confirm eligibility.

Study Sites (11)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia

São Paulo, São Paulo, Brazil

RECRUITING

Dept. Anesthesia, The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

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

Montreal, Canada

RECRUITING

Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin

Berlin, Germany

RECRUITING

IRCCS Istituto Giannina Gaslini

Genova, 16147, Italy

RECRUITING

Kantonsspital Aarau, KSA

Aarau, Canton of Aargau, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6004, Switzerland

RECRUITING

Inselspital

Bern, 3010, Switzerland

RECRUITING

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

ACTIVE NOT 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 (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing: Will not share

Locations

IT(1)US(1)BR(1)AU(1)CH(4)DE(1)CA(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Intervention group

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Intervention group

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations