RecruitingACTRN12621001635853

Flexible Bronchoscopy Insufflated and High-Flow Nasal Oxygen Pilot Trial in Children


Sponsor

University of Queensland

Enrollment

80 participants

Start Date

May 3, 2022

Study Type

Interventional

Conditions

Summary

Infants and children with an abnormality in their airway and lungs often require procedures to further investigate their lungs and improve their breathing. During the anaesthesia for this procedure, the anaesthetist delivers oxygen and monitors the adequacy of the child’s breathing. In this situation both the proceduralist and the anaesthetist share the child’s airway for delivery of oxygen and for placement of a small telescope to directly view the anatomy within the airway and lungs. It is impractical for the anaesthetist to place a breathing tube into the airway for delivery of oxygen as this obstructs the view. It is not uncommon for the oxygen levels in the blood to fall (hypoxaemia) during these procedures. The procedure may need to be interrupted to correct this which can potentially compromise the safety of the child, prolong the procedure, increase exposure to anaesthetic agents and affect the success of the procedure. At Queensland Children’s Hospital, we reviewed the anaesthetic care of children undergoing flexible bronchoscopy procedures and found that 28% of children experienced low oxygen levels one or more times during the procedure. The method which the anaesthetist chooses to give the oxygen to the child may help to prevent the occurrence of low oxygen levels. Traditionally anaesthetists have delivered oxygen via face mask or airway device which is placed inside the mouth above the voice box part of the airway at flow rates of up to 6 litres per minute. Our research team have recently investigated a new mode of oxygen delivery called Nasal High. Flow. In Nasal High Flow, warm and humidified oxygen is delivered to the airway via nasal cannulae, at a rate determined by the child’s weight. For example, Nasal High Flow can be delivered at rates of 2L/kg/min. Therefore, a 10kg infant would receive 20 litres per minute. Matching the flow delivered to the patient’s breathing allows the anaesthetist to deliver oxygen to the child at the required concentration. Our recent studies have demonstrated Nasal High Flow is an effective alternative technique for oxygen delivery that can be safely used in infants and children with abnormal airways. To date there have been no large-scale studies evaluating Nasal High Flow in comparison to other oxygenation techniques during flexible bronchoscopy in children. Therefore, we aim to compare the two techniques using a randomised controlled trial in infants and children during flexible bronchoscopy. If we can determine that Nasal High Flow reduces the risk of low oxygen levels, this has the potential to both improve both the safety and the success of these procedures for children.


Eligibility

Sex: Both males and femalesMin Age: 0 WeekssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

When infants and children need a bronchoscopy — a procedure where a small flexible camera is passed into the lungs to investigate breathing problems — keeping their oxygen levels stable during the procedure can be challenging. Traditionally, oxygen has been delivered via a face mask or device at low flow rates, but this can sometimes be inadequate, causing oxygen levels to drop and requiring the procedure to be interrupted. Researchers at Queensland Children's Hospital have been developing a better approach using nasal high-flow oxygen — warm, humidified oxygen delivered through small tubes in the nose at much higher flow rates matched to the child's weight. This trial is comparing nasal high-flow oxygen to the traditional approach in children of all ages (from newborns to 16 years) during flexible bronchoscopy. The primary goal is to find out whether nasal high-flow oxygen reduces the risk of low oxygen levels occurring during the procedure, potentially making bronchoscopy safer and more successful. Your child may be eligible if they are up to 16 years old and are scheduled for an elective (non-emergency) flexible bronchoscopy. Children with choanal atresia (a specific nasal blockage), or who have had recent cranial or facial surgery, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: High flow nasal oxygen insufflation Description: High-Flow Nasal Oxygen Insufflation (HFNOI) is insufflation of heated (37 degrees Celsius) and humidified (100%) oxygen at weight-rela

Intervention: High flow nasal oxygen insufflation Description: High-Flow Nasal Oxygen Insufflation (HFNOI) is insufflation of heated (37 degrees Celsius) and humidified (100%) oxygen at weight-related flow rates matching peak inspiratory flow thereby allowing a known inspired fraction of inspired oxygen. HFNOI will be delivered during the bronchoscopy via the Optiflow™ device at weight-specific flow rates as per the table below delivering a FiO2 of 1.0. Weight HFNOI Flow rates 0-12 kg 2L/kg/min 13-15kg 30L/min 15-30 kg 35L/min 30-50 kg 40L/min >50 kg 50L/min Jaw thrust will be applied to ensure a patent airway until airway instrumentation begins. Anaesthesia will be maintained via a Total Intravenous Venous Anaesthesia (TIVA) using a combination of dexmedetomidine, propofol +/- an opioid (either remifentanil or alfentanil) at the discretion of the attending anaesthetist. Anaesthetists may wish to omit opioids in certain circumstances and this will be at the discretion of the anaesthetist e.g. neonates. Anaesthesia infusions will be adjusted to maintain both adequate depth of anaesthesia and spontaneous ventilation during the procedure. TIVA is used because inhalation agents can not be delivered when using HFNOI, TIVA is not the intervention of interest. The adherence to the intervention will be monitored by the research assistant present in the room collecting data and recorded on a case report form.


Locations(2)

Queensland Children's Hospital - South Brisbane

QLD,WA, Australia

Perth Children's Hospital - Nedlands

QLD,WA, Australia

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ACTRN12621001635853