Laryngoscopy for Neonatal and Infant aIrway Management wIth Supplemental oxygEn (OPTIMISE): a Multi-center Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Tracheal intubation first attempt success rate
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Day to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric patients requiring tracheal intubation for elective, semi-elective or urgent surgical and non-surgical indications either in the pediatric operating room, the pediatric or neonatal intensive care unit
- •Children aged up to 52 weeks (corrected gestational 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 mandating FiO2 < 1.0
- •cardiopulmonary collapse requiring advanced life support
- •intubation for emergency surgical and non-surgical indications
Arms & Interventions
VL-group
Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Germany) with blades Miller nr 0 and Miller nr 1.
Intervention: C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1. (Device)
DL-group
Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1
Intervention: Direct laryngoscope with blades Miller nr 0 and Miller nr 1. (Device)
Outcomes
Primary Outcomes
Tracheal intubation first attempt success rate
Time Frame: 15 minutes
Primary outcome is 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.
Secondary Outcomes
- Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy(5 minutes)
- Use of additional devices(10 minutes)
- Occurrence and duration of moderate and severe desaturation(15 minutes)
- Overall number of attempts(15 minutes)
- First EtCO2 after successful intubation(10 minutes)
- Respiratory complications(24 hours)
- Time required for intubation(5 minutes)