The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea (Apox-HFNO)
Primary Purpose
Apnea, Respiration; Arrest, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Apnoeic oxygenation
Sponsored by
About this trial
This is an interventional treatment trial for Apnea
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- ASA 1 or 2
- Receiving a general anaesthetic for non-emergent surgery
Exclusion Criteria:
- ASA score ≥3
- BMI ≥ 30 kg/m2
- Nasal obstruction
- Baseline SpO2 ≤95% on room air
- Anticipated difficult airway management
- Requirement for awake intubation
- Pregnancy
- Positive PCR test for coronavirus in preceding 14 days.
Sites / Locations
- University Hospital Galway
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Apnoea without apnoeic oxygenation
Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO)
Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO)
Arm Description
High-flow nasal oxygen administration ceases at the onset of apnoea.
100% oxygen is administered via high-flow nasal cannulae at 70L/min from the onset of apnoea until four minutes of apnoea has completed.
100% oxygen is administered via high-flow nasal cannulae at 120L/min from the onset of apnoea until four minutes of apnoea has completed.
Outcomes
Primary Outcome Measures
Rise in arterial partial pressure of carbon dioxide
The rate of rise of the partial pressure of carbon dioxide between 60 seconds and 240 seconds of apnoea as measured by arterial blood gas analysis.
Secondary Outcome Measures
Partial pressure of oxygen during apnoea
As measured by blood gas analysis
Time to oxygen desaturation
The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.
Change in carbon dioxide elevation before and after HFNO administration
As measured by blood gas analysis
Carbon dioxide elevation during the first minute of apnoea
As measured by blood gas analysis
Change in acid-base status during apnoea
As measured by blood gas analysis
Full Information
NCT ID
NCT05124093
First Posted
November 5, 2021
Last Updated
July 8, 2022
Sponsor
University College Hospital Galway
1. Study Identification
Unique Protocol Identification Number
NCT05124093
Brief Title
The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea
Acronym
Apox-HFNO
Official Title
A Randomised Controlled Trial of Apnoeic Oxygenation With No-flow vs High-flow vs Ultra High-flow Nasal Oxygen
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.
Detailed Description
Apnoeic oxygenation with high-flow nasal oxygen has been proposed to result in carbon dioxide clearance. However, this has been poorly quantified.
This study will compare use of nasal oxygen at different flow rates during apnoea with that of a control that does not receive nasal oxygen. Participants are anaesthetised after standardised pre-oxygenation with high-flow nasal oxygen, after which they will receive one of three nasal oxygen flow rates (0, 70, 120 L/min).
The rate of carbon dioxide elevation will be measured by arterial blood gas analysis after the onset of apnoea and compared between the three groups to discern the relative rates of carbon dioxide clearance after the first minute of apnoea. The effect of nasal oxygen flow rate on oxygenation will also be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Respiration; Arrest, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apnoea without apnoeic oxygenation
Arm Type
Placebo Comparator
Arm Description
High-flow nasal oxygen administration ceases at the onset of apnoea.
Arm Title
Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO)
Arm Type
Active Comparator
Arm Description
100% oxygen is administered via high-flow nasal cannulae at 70L/min from the onset of apnoea until four minutes of apnoea has completed.
Arm Title
Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO)
Arm Type
Active Comparator
Arm Description
100% oxygen is administered via high-flow nasal cannulae at 120L/min from the onset of apnoea until four minutes of apnoea has completed.
Intervention Type
Procedure
Intervention Name(s)
Apnoeic oxygenation
Intervention Description
After 2mins 45 seconds of pre-oxygenation with high-flow nasal oxygen at Fio2 1.0 at 50L/min, anaesthesia is induced with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions administered until study conclusion.
At the onset of apnoea, 1mg/kg rocuronium administered. Jaw thrust performed. High-flow nasal oxygen adjusted to the randomised flow rate. Videolaryngoscopy after 1 minute of apnoea. Airway patency maintained. Tracheal intubation after 4 minutes of apnoea.
Positive pressure ventilation commenced at Spo2 92%. Failure to obtain view of glottis with videolaryngoscope results in withdrawal from the study.
Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after each minute of apnoea until six minutes of apnoea, and every two minutes of apnoea thereafter, until Spo2 92%.
Primary Outcome Measure Information:
Title
Rise in arterial partial pressure of carbon dioxide
Description
The rate of rise of the partial pressure of carbon dioxide between 60 seconds and 240 seconds of apnoea as measured by arterial blood gas analysis.
Time Frame
Between 1 and 4 minutes of apnoea
Secondary Outcome Measure Information:
Title
Partial pressure of oxygen during apnoea
Description
As measured by blood gas analysis
Time Frame
Following high-flow nasal oxygen administration
Title
Time to oxygen desaturation
Description
The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.
Time Frame
Immediately after the intervention
Title
Change in carbon dioxide elevation before and after HFNO administration
Description
As measured by blood gas analysis
Time Frame
Between 3 and 5 minutes of apnoea
Title
Carbon dioxide elevation during the first minute of apnoea
Description
As measured by blood gas analysis
Time Frame
Between 0 and 1 minute of apnoea
Title
Change in acid-base status during apnoea
Description
As measured by blood gas analysis
Time Frame
At 1 minute intervals during apnoea
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
ASA 1 or 2
Receiving a general anaesthetic for non-emergent surgery
Exclusion Criteria:
ASA score ≥3
BMI ≥ 30 kg/m2
Nasal obstruction
Baseline SpO2 ≤95% on room air
Anticipated difficult airway management
Requirement for awake intubation
Pregnancy
Positive PCR test for coronavirus in preceding 14 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Callaghan, MB BCh BAO
Organizational Affiliation
Consultant Anaesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The sharing of anonymised patient-specific data that underlie results in any publication.
IPD Sharing Time Frame
Post publication of results for up to fifteen years
IPD Sharing Access Criteria
Investigator will consider requests to share patient-specific anonymised data in electronic format for the purpose of meta-analysis
Learn more about this trial
The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea
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