Clinical trial NCT05846919: High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children
Official title: High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rapid Sequence Induction (RSI)
Preoxygenation
Keywords: Rapid sequence induction (RSI)
High flow nasal oxygenation (HFNO)
High flow nasal cannula (HFNC)
preoxygenation
children
pediatric
infant
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2023-05-06
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple group randomized controlled pilot trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management. The risk could be greater considering anaesthesia in children and neonates because of their anatomical and physiological differences. Children and neonates are more susceptible to hypoxia and bradycardia during induction of anaesthesia, this risk is even greater during the rapid sequence induction/intubation (RSI), in which there is an apnoeic pause because of the absence of manual ventilation. Because of the pause it is necessary to provide enough oxygen in advance during preoxygenation. The aim of this trial is to compare providing oxygen by face-mask and by high-flow nasal oxygen cannula. Another outcome is to evalute the safety profile RSI in children and neonates.

Detailed description: All patients requiring an acute surgery and rapid sequence induction/intubation will be checked for eligibility criteria and then an informed consent will be obtained. Afterwards, randomization will take place, which will divide a patient into one of three groups: 1) RSI + face-mask preoxygenation, 2) RSI + high-flow nasal oxygen cannula (HFNOC) preoxygenation and 3) RSI + face-mask and HFNOC preoxygenation.

The demographic data, type of surgery and vital signs will be observed. Primary outcomes will be the impact of HFNOC preoxygenation on oxygen saturation by pulse oximetry (SpO2) and heart rate during the induction of anaesthesia. Secondary outcomes will be safety of the RSI protocol, Cormack-Lehane score, incidence of difficult airway management, number of the intubation attempts and episodes of regurgitation/aspiration.

RSI will be done according to our protocol. Initially, equipment will be checked and an i.v. line will be checked/started and then a bolus of ketamine will be given (0,2-0,5 mg/kg intravenously,) for the face-mask/HFNOC tolerance and the table will be tilted to anti-Trendelenburg position. In case of difficult or unable of intravenous line insertion, intramuscular bolus of ketamin (1-3mg/kg i.m.) could be used prior to another attempt. Afterward, the preoxygenation will start according to the randomization result - group 1) face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute), group 2) HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) and group 3) HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. Then a bolus of anaesthetic and myorelaxant agent will be given (propofol 2,5 mg/kg in haemodynamically stable, ketamine in haemodynamically unstable and rocuronium 1 mg/kg or suxamethonium 1,5 mg/kg if sugammadex bolus was given in last 24 hours). The neuromuscular blockade will be monitored, first intubation attempt will start as soon as single twitch will be bellow 10 % or train-of-four (TOF) bellow 1 or after 60 seconds, whichever comes first. After that, the first intubation attempt will take place, a video laryngoscopy will be used and Cormack-Lehane score will be documented photographically. The attempt will end either by successful intubation with monitored capnography wave or by failure.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients indicated for rapid sequence induction
* informed consent

Exclusion Criteria:

* decline to participate
* rapid sequence induction not required for anesthesia induction

Primary outcomes:
measure: Incidence of desaturation under 90%
timeFrame: Intraoperatively
measure: Incidence of manual ventilation during RSI
timeFrame: Intraoperatively
Secondary outcomes:
measure: Incidence of desaturation under 80%
timeFrame: Intraoperatively
measure: time to desaturation under 90%
timeFrame: Intraoperatively
measure: time to desaturation under 80%
timeFrame: Intraoperatively
measure: time needed for relaxation
timeFrame: Intraoperatively
measure: time needed for intubation
timeFrame: Intraoperatively
measure: time to reach oxygen saturation 100%
timeFrame: Intraoperatively
measure: First intubation attempt success rate
timeFrame: Intraoperatively
measure: Number of intubation attempts to successful intubation
timeFrame: Intraoperatively
measure: Intubation conditions
timeFrame: Intraoperatively
measure: Incidence of complications
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References: