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

NCT ID: NCT05846919

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2025-07-01

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.

Conditions

Rapid Sequence Induction (RSI); Preoxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Pediatric patients indicated for RSI and face-mask preoxygenation

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

Group Type: ACTIVE_COMPARATOR

face-mask preoxygenation

Intervention Type: PROCEDURE

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

Pediatric patients indicated for RSI and HFNOC preoxygenation

HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.

Group Type: ACTIVE_COMPARATOR

HFNOC preoxygenation

Intervention Type: PROCEDURE

HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.

Pediatric patients indicated for RSI and 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.

Group Type: EXPERIMENTAL

HFNOC + face-mask preoxygenation

Intervention Type: PROCEDURE

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

Interventions

face-mask preoxygenation

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

Intervention Type: PROCEDURE

HFNOC preoxygenation

HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk University

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Stourac, prof. MD., Ph.D., MBA

Role: STUDY_CHAIR

Department of paediatric anaesthesia and intensive care medicine

Locations

Brno University Hospital

Brno, South Moravian, Czechia

Countries

Czechia

Other Identifiers

KDAR PRSI-START-UP

Identifier Type: -

Identifier Source: org_study_id