RecruitingACTRN12619000652178

A study to investigate the utility of Optiflow for Pre oxygenation.

A study to investigate the utility of Optiflow for Pre oxygenation prior to anaesthesia.


Sponsor

Fisher & Paykel Healthcare

Enrollment

90 participants

Start Date

Oct 28, 2020

Study Type

Interventional

Conditions

Summary

This study aims to answer the question: Is nasal high flow (Optiflow) efficacious for pre-oxygenation? Pre oxygenation is carried out before the induction of anaesthesia to fill the patient's lungs with Oxygen to prolong safe apnoea time. Usual practice is to perform preoxygenation with a bag and mask but this technique has some usability and patient comfort issues. Nasal high flow has been reported to be well tolerated in a number of patient groups and may provide a useful alternative.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a nasal high-flow oxygen delivery system (Optiflow) can be used before anaesthesia is started — a phase called pre-oxygenation — as a more comfortable and effective alternative to the traditional face mask approach. Before giving a general anaesthetic, anaesthetists fill the lungs with oxygen to create a safety buffer in case breathing becomes difficult during the procedure. The face mask can be uncomfortable and sometimes does not seal well. Adults aged 18–80 who are scheduled for throat or airway surgery under general anaesthetic will be recruited to assess how effective Optiflow is at pre-oxygenating the lungs, compared to standard face mask pre-oxygenation, by measuring oxygen levels in the blood. You may be eligible if you are aged 18–80, are having laryngotracheal surgery under general anaesthetic expected to last at least 15 minutes, and can give informed consent. People with a BMI over 35, severe lung disease, low baseline oxygen levels, certain contraindications to high-flow oxygen, skull base defects, bleeding in the nose or throat, or specific anaesthetic requirements cannot participate. This study is sponsored by Fisher & Paykel Healthcare and aims to make the induction of anaesthesia more comfortable and safer.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will receive four minutes of 50l/min of Nasal High Flow delivered from a prototype flow source, a humidifier, a water chamber, a breathing tube, and a non sealing nasal interface. The treatme

Patients will receive four minutes of 50l/min of Nasal High Flow delivered from a prototype flow source, a humidifier, a water chamber, a breathing tube, and a non sealing nasal interface. The treatment will be administered in an operating room under the direction of an anaesthetist immediately prior to induction of anaesthesia The case report form will record the duration of the intervention, the flows delivered and any variations to the protocol. This study is being conducted with the same participants as another study (ACTRN12619000613101). The studies have distinct hypotheses and endpoints and will be conducted in series, with this study to be conducted immediately prior to induction of anaesthesia whereas the other study will be conducted after the induction of anaesthesia.


Locations(1)

auckland, New Zealand

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ACTRN12619000652178