High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children: Pilot Randomized Controlled Trial

Conditions
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Rapid Sequence Induction (RSI), Preoxygenation

Intervention / Treatment
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* Procedure: face-mask preoxygenation
* Procedure: HFNOC preoxygenation
* Procedure: HFNOC + face-mask preoxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients indicated for rapid sequence induction informed consent Exclusion Criteria: decline to participate rapid sequence induction not required for anesthesia induction

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Triple group randomized controlled pilot trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pediatric patients indicated for RSI and face-mask preoxygenation<br>face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. | Procedure: face-mask preoxygenation<br>* face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.<br>|
| Active Comparator: Pediatric patients indicated for RSI and HFNOC preoxygenation<br>HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. | Procedure: HFNOC preoxygenation<br>* HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.<br>|
| Experimental: Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation<br>HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. | Procedure: HFNOC + face-mask preoxygenation<br>* HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturation under 90% | peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded | Intraoperatively | 
| Incidence of manual ventilation during RSI | incidence of manual ventilation during preoxygenation due to desaturation will be evaluated | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturation under 80% | peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded | Intraoperatively | 
| time to desaturation under 90% | peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the time to reach saturation below 90% will be recorded | Intraoperatively | 
| time to desaturation under 80% | peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the time to reach saturation below 80% will be recorded | Intraoperatively | 
| time needed for relaxation | time between the induction dose and the optimal intubation conditions (defined by accelerometry - single twitch below 10%, or TOF below 1, or post-tetanic count - PTC tracing) will be recorded | Intraoperatively | 
| time needed for intubation | time between the induction dose and first capnography tracing will be recorded | Intraoperatively | 
| time to reach oxygen saturation 100% | time between the preoxygenation initiation and the 100% oxygen saturation between the groups will be recorded | Intraoperatively | 
| First intubation attempt success rate | First intubation attempt success rate | Intraoperatively | 
| Number of intubation attempts to successful intubation | Number of intubation attempts to successful intubation | Intraoperatively | 
| Intubation conditions | Intubation conditions defined by Cormack-Lehane score | Intraoperatively | 
| Incidence of complications | Incidence of complications - aspiration, regurgitation, difficult intubation | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid sequence induction (RSI), High flow nasal oxygenation (HFNO), High flow nasal cannula (HFNC), preoxygenation, children, pediatric, infant