CompletedPhase 4ACTRN12616001691437

High Flow Nasal Oxygen during Endobronchial Ultrasound to prevent low oxygen levels.

High flow humidified nasal oxygen to prevent desaturation during EBUS – a randomised controlled trial


Sponsor

Royal Melbourne Hospital

Enrollment

60 participants

Start Date

Feb 1, 2017

Study Type

Interventional

Conditions

Summary

Endobronchial ultrasound (EBUS) is a procedure performed to extract tissue from the lung to aid diagnosis of lung cancer, infections and sarcoidosis. To tolerate this procedure, which involves a camera on a tube being inserted into the lung, patients require sedation. The sedative medications commonly cause patients to hypoventilate, and a reduction in oxygen saturation and increase in carbon dioxide level is commonly seen, necessitating the interruption of the procedure, and occasionally putting patient’s lives at risk. An intervention to reduce the rates of these problems may make the procedure safer. The OptiFlow THRIVE device delivers high flow oxygen via the nose, and may reduce the rate of desaturation and limit the rate of increase in CO2 level. The device has been trialed in anaesthesia in morbid obesity surgery, difficult airways in ENT and during awake fibreoptic intubation, which is a conceptually similar procedure to EBUS. The device has been used safely for many years to assist intubation in the emergency department and intensive care unit. There is no data currently using the device during EUBS, or any endoscopic procedure for that matter. This study will randomize participants to either oxygen therapy during sedation with standard care (being a gutter mask) or OptiFlow THRIVE. The research question is: In adults undergoing endobronchial ultrasound, does oxygen therapy provided using the OptiFlow THRIVE device reduce the frequency of desaturation and hypercarbia compared to standard oxygen therapy using a gutter mask?


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Adults aged greater than or equal to 18 years
  • Able to give informed consent
  • Planned for endobronchial ultrasound and
  • Planned for sedation for their endobronchial ultrasound

Exclusion Criteria5

  • Unable to give informed consent
  • Intubated, or planned for intubation or general anaesthesia for their endobronchial ultrasound
  • Pregnant patients
  • Patients with active nasal bleeding or base of skull fracture
  • Non-english speaking patients

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Interventions

High flow humidified nasal oxygen. Oxygen administered via the Optiflow THRIVE device, at a flow rate of 50-70LPM as tolerated, humidified using the Fisher and Paykel 850 humidifier, to a humidity of

High flow humidified nasal oxygen. Oxygen administered via the Optiflow THRIVE device, at a flow rate of 50-70LPM as tolerated, humidified using the Fisher and Paykel 850 humidifier, to a humidity of 70% relative humidity. The oxygen concentration delivered from the device will be 100%, but the actual inspired oxygen concentration will vary with the patient's inspiratory flow rate and degree of air entrainment. In the intervention group, patients will be put on a THRIVE device with oxygen delivering at 30 L/min immediately upon entering the room, but before sedation administration, for a minimum of 3 minutes. The oxygen delivering rate will be increased to 50 L/min via the THRIVE device immediately after sedation agent is given and will be maintained at 50 L/min during the procedure. The flow rate can be increased up to 70L/min if necessary by the anaesthetist or decreased to 30L/min if patient is not tolerating the device. The EBUS procedure will only commence once a clinically appropriate level of sedation is reached, titrated by the anaesthetist. As such, oxygen administration will have occurred for a minimum of 3-5minutes before the procedure begins. Oxygen delivery will continue until the conclusion of the EBUS procedure, and will be removed when the patient is stable for transfer to the recovery room, as judged by the anaesthetist.


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12616001691437


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