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

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: Recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope; Device: High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope

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: Interventional
• Enrollment (Estimated): 1192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Fuchs, MD; Phone Number: +41 31 632 52 01; Email: alexander.fuchs@insel.ch
• Study Contact Backup: Name: Thomas Riva, MD; Phone Number: +41 31 632 17 09; Email: thomasriva@me.com

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Recruiting
      • Perth Children's Hospital
      • Contact: Britta von Ungern Sternberg, Prof; Phone Number: +08 6456 2222; Email: britta.regli-vonungern@uwa.edu.au
      • 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: Vinicius Quintao, Prof; Phone Number: +55 11 3016-0500; Email: vinicius.quintao@hc.fm.usp.br
      • Principal Investigator: Vinicius Quintao, MD
• Canada
  • Montreal, Canada
    • Recruiting
    • Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
    • Contact: Thomas Engelhardt, Prof.; Email: thomas.engelhardt@mcgill.ca
    • Principal Investigator: Thomas Engelhardt, MD
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Dept. Anesthesia, The Hospital for Sick Children
      • Contact: Clyde Matava, Prof.; Email: clyde.matava@sickkids.ca
      • Principal Investigator: Clyde Matava, MD
• Germany
  • Berlin, Germany
    • Recruiting
    • Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
    • Contact: Maren Kleine-Brueggeney, Prof. Dr.; Email: maren.kleine-brueggeney@dhzc-charite.de
    • Principal Investigator: Maren Kleine-Brueggeney, MD
• Italy
  • Genova, Italy, 16147
    • Recruiting
    • IRCCS Istituto Giannina Gaslini
    • Principal Investigator: Nicola Disma, MD
    • Contact: Nicola Disma, Prof; Phone Number: +39 010 56361; Email: nicoladisma@gaslini.org
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital
    • Contact: Thomas Riva, MD; Phone Number: 41316321709; Email: thomas.riva@insel.ch
    • Contact: Alexander Fuchs, MD; Phone Number: 41316321709; Email: alexander.fuchs@insel.ch
    • 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: Lorenz Theiler, Prof; Phone Number: +41 062 838 41 41; Email: lorenz.theiler@ksa.ch
      • Principal Investigator: Lorenz Theiler, MD
  • Canton of Lucerne
    • Lucerne, Canton of Lucerne, Switzerland, 6004
      • Recruiting
      • Luzerner Kantonsspital
      • Contact: Martin Hoelzle, MD; Phone Number: +41 41 205 61 11; Email: martin.hoelzle@luks.ch
      • Principal Investigator: Martin Hoelzle, MD
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Annery Garcia Marcinkiewicz, Professor; Phone Number: 800-879-2467; Email: garciamara@chop.edu
      • Principal Investigator: Annery Garcia Marcinkiewicz, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall number of intubation attempts	Overall number of intubation attempts	15 minutes
First attempt success rate of tracheal intubation	First attempt success rate of tracheal intubation	15 Minutes
Time required for intubation	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	Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation	10 minutes
Cormack-Lehane score	Cormack-Lehane score at any attempt of laryngoscopy	5 minutes
The need for additional devices	The need for additional devices used at any step of intubation	5 minutes
Respiratory complications	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	Duration of moderate and severe desaturation (SpO2 < 80%), with or without bradycardia, during intubation.	15 minutes
Percentage of Glottic Opening (POGO) score	Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy, (0-100%). 100% best glottic opening	5 minutes
Occurrence of severe desaturation	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

• Sponsor: Thomas Riva
• Collaborators: 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: Study Chair: Thomas Riva, MD, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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