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

May 9, 2026 updated by: Thomas Riva

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 protocol:

  • A neuromuscular blocking agent (NMBA): Rocuronium 0.5-1 mg/kg, Cis-Atracurium 0.2-0.5 mg/kg, Atracurium 0,5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2 - 0.3 mg/kg or Succinylcholine 2 mg/kg.
  • One or more of the following hypnotic agents (Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, Sevoflurane up to 8%).
  • An opioid drug and anticholinergic can be chosen and administered at the discretion of the anesthetist in charge.

Before intubation: After induction of anesthesia and the administration of a NMBA, bag-mask ventilation with FiO2 1.0 (flow rates of 6-10 L/min) will be performed for 60 seconds until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Full neuromuscular blockade will be assessed by train-of-four (TOF) monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed.

During intubation: The administration of oxygen during intubation is mandatory for every study participant and is randomized as follows:

Low-flow Oxygen Group: For orally intubated children, the administration of low-flow oxygen (0.2 L/kg/min FiO2 1.0) takes place via conventional nasal cannula (Intersurgical, Wokingham, UK). For nasally intubated children, the administration of low-flow oxygen (0.2 L/kg/min FiO2 1.0) takes place via a nasal oxygen sponge cannula (Vygon, Ecouen, France) adapted to the dimension of nare. After administration of low-flow oxygen laryngoscopy and tracheal intubation are performed.

High-Flow Oxygen Group (control-group): For all orally intubated children, the administration of high-flow oxygen (2 L/kg/min FiO2 1.0) takes place via nasal cannula with the Optiflow (Fisher & Paykel Healthcare, Auckland, New Zealand). For nasally intubated children, the administration of low-flow oxygen (2 L/kg/min FiO2 1.0) takes place via the anaesthesia circuit through the tracheal tube placed in the nose. After administration of high-flow oxygen laryngoscopy and tracheal intubation are performed.

For a premature neonate < 1kg an uncuffed tube ID 2.5 will be used. For premature babies and newborn between 1kg and 3.0 kg an uncuffed tube ID 3.0 will be used. For babies > 3.0 kg - 8 months a cuffed tube ID 3.0 or an uncuffed tube 3.5 will be used. For infants 8 months - 12 months a cuffed tube ID 3.5 or an uncuffed tube 4.0 will be used. Based on the group of randomization, the child will receive supplemental oxygen low-flow via a conventional nasal cannula vs high-flow with the Optiflow (Fisher & Paykel Healthcare, Auckland, New Zealand).

Miller-blade or Macintosh-blade size No. 0 will be used for children < 1 kg. In cases of unexpected difficult intubation, the difficult airway algorithm (18) will be followed. After the first unsuccessful intubation attempt with the randomized flowrate, the investigators encourage to perform a second attempt with the same rate but based on the clinical judgment the intubating physician can proceed to an attempt with the same technique, or change the flow rate, blade size or the type of laryngoscope. A maximum of 4 intubation attempts in total will be performed. The last intubation attempt must be performed by the most experienced physician in the room. Additional devices like stylet, bougie, etc., can be used at any stage of the intubation process. If the intubation remains unsuccessful the difficult airway algorithm will be followed (Appendix) and a supraglottic airway - SGA will be inserted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
        • Contact:
        • Principal Investigator:
          • Britta von Ungern Sternberg, MD
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil
        • Recruiting
        • Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia
        • Contact:
        • Principal Investigator:
          • Vinicius Quintao, MD
  • Canada
      • Montreal, Canada
        • Recruiting
        • Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Thomas Engelhardt, MD
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Dept. Anesthesia, The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Clyde Matava, MD
  • Germany
      • Berlin, Germany
        • Recruiting
        • Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
        • Contact:
        • Principal Investigator:
          • Maren Kleine-Brueggeney, MD
  • Italy
      • Genova, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Principal Investigator:
          • Nicola Disma, MD
        • Contact:
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander Fuchs, MD
      • Lausanne, Switzerland, 1011
        • Active, not recruiting
        • CHUV Centre Hospitalier Universitaire Vaudois
    • Canton of Aargau
      • Aarau, Canton of Aargau, Switzerland
        • Recruiting
        • Kantonsspital Aarau, KSA
        • Contact:
        • Principal Investigator:
          • Lorenz Theiler, MD
    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Switzerland, 6004
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
        • Principal Investigator:
          • Martin Hoelzle, MD
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Annery Garcia Marcinkiewicz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First attempt success rate
Time Frame: 15 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall number of intubation attempts
Time Frame: 15 minutes
Overall number of intubation attempts
15 minutes
First attempt success rate of tracheal intubation
Time Frame: 15 Minutes
First attempt success rate of tracheal intubation
15 Minutes
Time required for intubation
Time Frame: 5 minutes
Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography)
5 minutes
First EtCO2 after successful intubation
Time Frame: 10 minutes
Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation
10 minutes
Cormack-Lehane score
Time Frame: 5 minutes
Cormack-Lehane score at any attempt of laryngoscopy
5 minutes
The need for additional devices
Time Frame: 5 minutes
The need for additional devices used at any step of intubation
5 minutes
Respiratory complications
Time Frame: 24 hours
Respiratory complications or complications of airway management within the first 24 hours, such as airway injury, cardiopulmonary resuscitation, bleeding, aspiration of gastric contents, post-extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded. Respiratory complications are defined as the need for re-intubation after being extubated, persistent stridor (even if oxygen is not required), respiratory failure, the occurrence of pneumothorax or the need for any additional diagnostic examination following respiratory problems (i.e., bronchoscopy, radiology).
24 hours
Duration of severe desaturation
Time Frame: 15 minutes
Duration of moderate and severe desaturation (SpO2 < 80%), with or without bradycardia, during intubation.
15 minutes
Percentage of Glottic Opening (POGO) score
Time Frame: 5 minutes
Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy, (0-100%). 100% best glottic opening
5 minutes
Occurrence of severe desaturation
Time Frame: 15 minutes
Occurrence and duration of moderate and severe desaturation (SpO2 < 10% and SpO2 < 20% from baseline), with or without bradycardia, during intubation.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Riva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hospital for Sick Children
Children's Hospital of Philadelphia
Charite University, Berlin, Germany
University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois
Kantonsspital Aarau
Perth Children's Hospital
Istituto Giannina Gaslini
Montreal Children's Hospital of the MUHC
Cantonal Hospital of Lucerne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Thomas Riva, MD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPTIMISE-2-trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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