Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846919
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-04-17
Brief Title:
High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children
Sponsor:
Brno University Hospital
Organization:
Brno University Hospital
Study Overview
Official Title:
High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRSIHFO
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 inductionintubation 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 inductionintubation 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 regurgitationaspiration
RSI will be done according to our protocol Initially equipment will be checked and an iv line will be checkedstarted and then a bolus of ketamine will be given 02-05 mgkg intravenously for the face-maskHFNOC 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 1-3mgkg im could be used prior to another attempt Afterward the preoxygenation will start according to the randomization result - group 1 face-mask preoxygenation flow 2 Lkgminute max 6 Lminute group 2 HFNOC preoxygenation flow 2 Lkgminute max 6 Lminute and group 3 HFNOC flow 2 Lkgminute face-mask preoxygenation flow 2 Lkgminute max 6 Lminute - with 100 oxygen for three minutes Then a bolus of anaesthetic and myorelaxant agent will be given propofol 25 mgkg in haemodynamically stable ketamine in haemodynamically unstable and rocuronium 1 mgkg or suxamethonium 15 mgkg 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
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 regurgitationaspiration
RSI will be done according to our protocol Initially equipment will be checked and an iv line will be checkedstarted and then a bolus of ketamine will be given 02-05 mgkg intravenously for the face-maskHFNOC 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 1-3mgkg im could be used prior to another attempt Afterward the preoxygenation will start according to the randomization result - group 1 face-mask preoxygenation flow 2 Lkgminute max 6 Lminute group 2 HFNOC preoxygenation flow 2 Lkgminute max 6 Lminute and group 3 HFNOC flow 2 Lkgminute face-mask preoxygenation flow 2 Lkgminute max 6 Lminute - with 100 oxygen for three minutes Then a bolus of anaesthetic and myorelaxant agent will be given propofol 25 mgkg in haemodynamically stable ketamine in haemodynamically unstable and rocuronium 1 mgkg or suxamethonium 15 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None