Laryngoscopy for Neonatal and Infant aIrway Management (Optimise-Trial)
Condition: Airway Management
Study type: Interventional

Summary: 
      The objective of this study is to compare tracheal intubation first attempt success rate with
      the C-MAC indirect videolaryngoscope (Karl Storz, Germany) using a Miller-Blade nr 0 or nr 1
      compared to a standard direct laryngoscope with standard blades Miller nr 0 and Miller nr 1
      with oxygen supplementation either in the operating room or intensive care to demonstrate
      that with oxygen supplementation the difference in the first-attempt success rate in favor of
      VL is negligible
    

Detailed description: 
      Eligible children will be prepared for intubation according to the local SOPs of the
      pediatric anesthesia or pediatric intensive care departments. Mandatory monitoring will
      consist of: SpO2, HR, NIBP.

      Induction of anesthesia: 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 non-depolarizing muscle relaxant (NDMR) drug (Rocuronium 0.5-1 mg/kg, Cis-Atracurium
           0.2-0.5 mg/kg, Vecuronium 0.1 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 muscle relaxant
      drug, bag-mask ventilation with FiO2 = 1.0 (flow rates of 6-10 Lmin-1) will be performed for
      60 seconds until apnea sets in. After induction all patients will be paralysed with e.g.
      0.5-1 mg/kg of rocuronium (2 x ED95 (standard intubation dose)) to facilitate airway
      management. 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 standardized as follows:

        -  Oral intubation: For all orally intubated children, the administration of low-flow
           oxygen (1 l/kg/min) takes place via conventional neonatal nasal cannula. After
           administration of low-flow oxygen laryngoscopy and tracheal intubation are performed.

        -  Nasal intubation: For all nasally intubated children, the administration of low-flow
           oxygen (1 l/kg/min) takes place direct via nasal tube. The nasal tube is introduced into
           one of the two nostrils up to the nasopharyngeal space and oxygen is applied to the tube
           via oxygen cannula. After administration of low-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 a
      cuffed tube ID 3.0 or an uncuffed tube 3.5 will be used. The tube will be either passed
      through one of the two nostrils and advanced with the help of a Magill-forceps or through the
      mouth. Based on the group of randomization, the child will be intubated either using the
      C-MAC videolaryngoscope with a Miller blade 1 (Karl Storz, Germany) or using standard direct
      laryngoscope, with standard blades Miller nr 0 and Miller nr 1.

      Miller blade nr 0 will be used for children < 1 kg. In cases of unexpected difficult
      intubation, the difficult airway algorithm (14) will be followed. After the first
      unsuccessful intubation attempt with the randomized device, the investigators encourage to
      perform a second attempt with the same device but based on the clinical judgment the
      intubating physician can proceed to an attempt with the same technique, or change the
      laryngoscope blade size, switch from one technique to another and 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 and a supraglottic airway device - SAD will be
      inserted.
    

Intervention name(s): C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1.; Direct laryngoscope with blades Miller nr 0 and Miller nr 1.
Intervention type(s): Device; Device
Intervention description(s): Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Tuttlingen, Germany) with blades Miller nr 0 and Miller nr 1.; Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1
Other intervention name(s): C-Mac Videolaryngoscope; Standard direct laryngoscope
Intervention MeSH terms: Pyrithione zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention