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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

Desaturation/oxygenation during anaesthesia

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

Inclusion Criteria3

  • years and over and less than 80 years in age
  • Capable of informed consent
  • Undergoing laryngotrachael surgery under general anaesthetic expected to last at least 15 minutes

Exclusion Criteria16

  • BMI > 35 kg/m2.
  • Patients who are deemed unfit for general anaesthesia and/or THRIVE treatment by the anaesthetist.
  • Room-air saturation levels <85%
  • requiring preoperative oxygen therapy secondary to chronic lung disease
  • Pre-existing hypoxemia
  • clinically-defined severe concomitant lower airway pulmonary disease
  • Known contraindication to Optiflow™ device
  • Patients in whom CPAP is contraindicated (e.g. pneumothorax, bullous lung disease, craniofacial trauma, airway, foreign body, unstable haemodynamics)
  • history or symptoms of increased intracranial pressure or reduced intracranial compliance ( e.g. headaches, nausea and vomiting, visual changes, mental changes) .
  • skull base defects.
  • Patients in whom high FiO2 is contraindicated (e.g. patients being treated with Bleomycin)
  • Patients undergoing procedures with electrocautery or laser.
  • More than 50% (as judged by the anaesthetist) of the nares occluded by the nasal prongs
  • Bleeding in nose or oropharynx
  • Patients receiving an induction with volatile anaesthetics
  • Patients with delicate skin that could be thermally damaged by the transcutaneous monitor

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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