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

Preoxygenation Clinical Trial

— PRSIHFO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846919
• Other study ID #: KDAR PRSI-START-UP
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Brno University Hospital
• Contact: Dominik Fabian, MD
• Phone: 532234695
• Email: fabian.dominik[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Pediatric patients indicated for rapid sequence induction

• informed consent

Exclusion Criteria:

• decline to participate

• rapid sequence induction not required for anesthesia induction

Related Conditions & MeSH terms

• Preoxygenation

Intervention

Procedure:
• face-mask preoxygenation
face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.
• HFNOC preoxygenation
HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.
• HFNOC + face-mask preoxygenation
HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes.

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of manual ventilation during RSI	incidence of manual ventilation during preoxygenation due to desaturation will be evaluated	Intraoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	time needed for intubation	time between the induction dose and first capnography tracing will be recorded	Intraoperatively
Secondary	time to reach oxygen saturation 100%	time between the preoxygenation initiation and the 100% oxygen saturation between the groups will be recorded	Intraoperatively
Secondary	First intubation attempt success rate	First intubation attempt success rate	Intraoperatively
Secondary	Number of intubation attempts to successful intubation	Number of intubation attempts to successful intubation	Intraoperatively
Secondary	Intubation conditions	Intubation conditions defined by Cormack-Lehane score	Intraoperatively
Secondary	Incidence of complications	Incidence of complications - aspiration, regurgitation, difficult intubation	Intraoperatively