Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery
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|ClinicalTrials.gov Identifier: NCT02780518|
Recruitment Status : Withdrawn (Airvo 2 not suitable for CO2 clearance, awaiting Optiflow THRIVE machine)
First Posted : May 23, 2016
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Throat Disorders||Device: Airvo||Not Applicable|
Optiflow high flow nasal cannula (HFNC) oxygenation is a suitable technique for oxygenation and ventilation (apnoeic ventilation) for patients undergoing microlaryngeal surgery.
- Measure continuous pulse oximetry (oxygenation) and intermittent subglottic catheter sampling of end tidal carbon dioxide levels (ventilation) in the distal trachea during HFNC oxygenation
- Measure intra-tracheal airway pressure during HFNC oxygenation
As a pilot study, the investigators will recruit up to 20 patients within a 12 month period scheduled for elective microlaryngeal surgery and high frequency jet ventilation. Standard monitoring and standard conduct of anaesthesia will be carried out: induction of general anaesthesia, insertion of a narrow catheter into the trachea and insertion of laryngeal mask airway. In addition, the study device (HFNC) will be placed into the entrance of the patient's nostrils. After removal of the laryngeal mask, HFNC oxygenation will commence. A surgical suspension laryngoscope will be inserted for microlaryngeal surgery (standard technique). The investigators will measure the adequacy of gas exchange, during of HFNC oxygenation and complications (cardiovascular, airway and respiratory). Data will be stored on a secure REDCap (Research Electronic Data Capture) system.
HFNC oxygenation is a novel technique that depends on apnoeic oxygenation. Even though the patient is paralysed and not breathing, oxygenation and carbon dioxide clearance still occurs. This is due to the difference between the alveolar rates of oxygen removal and carbon dioxide excretion which generates a negative pressure gradient. Oxygenation of the patient is therefore due to the high inspiratory fraction of oxygen, apnoeic ventilation and the small continuous positive airway pressure caused by the high flow of gas. This pressure increases lung volume and recruits collapsed alveoli. Carbon dioxide clearance is due to gas mixing and flushing of the airway dead space. The additional humidification of the high flow oxygen prevents mucociliary damage of the airway.
HFNC has been shown beneficial in pre-oxygenation, oxygenation after extubation, and in the treatment of respiratory failure and heart failure. New uses in difficult airway management are now emerging. However, the main case series of HFNC use in difficult airways did not measure intra-operative airway pressures end tidal oxygen and carbon dioxide; these gases were only measured at the end of surgery and when a definitive airway was inserted. As far as the investigators are aware, there are no data on intra-operative, intra-tracheal airway pressures or oxygen or carbon dioxide during HFNC oxygenation. Our study aim is to fill this knowledge gap.
Potential benefits and risks:
The use of HFNC removes obstacles form the surgical field and this may make surgery easier and quicker to perform. Risks include: failed gas exchange, but this is minimized by abandoning HFNC oxygenation and instituting tracheal catheter jet ventilation via the in situ jet catheter (standard practice).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery - Assessing Effectiveness of Oxygenation and Carbon Dioxide Clearance|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
All patients scheduled for elective microlaryngeal surgery under general anaesthesia and subglottic high frequency jet ventilation
Applying high flow nasal oxygen
- Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%). [ Time Frame: 30 minutes ]Continuous pulse oximetry will be monitored for participants during the study.
- Number of patients with inadequate carbon dioxide clearance (end tidal CO2>55 mmHg) [ Time Frame: 30 minutes ]End tidal carbon dioxide will be measured by the sublgottic catheter already in situ in the trachea by continuous passive sampling and by intermittent low frequency jet ventilation
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 30 minutes ]The investigator will report the number of participants wtih adverse events that are related to treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780518
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Patrick Wong, MBBS FRCA||Singapore General Hospital|