A Phase 4 interventional study of 0 L/min oxygen via conventional nasal cannulae and 15 L/min oxygen via conventional nasal cannulae in Apneic Oxygenation, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Nova Scotia Health Authority · Phase 4, Interventional, and Treatment
This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal cannulae in the post-induction setting for the purpose of prolonging the safe apneic time. Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group. The primary outcome will be the difference in the partial pressure of oxygen in arterial blood (PaO2) between groups throughout the nine-minute apneic period.
Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Strategies already exist to help prevent a lack of oxygen in the blood (hypoxemia), however research involving new ways to oxygenate patients may help to minimize the chance of hypoxemia during airway management. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannulae during airway management. Several different techniques to provide apneic oxygenation via nasal cannulae have been previously described(1-3), however randomized trials comparing these methods do not exist. This study will examine the change over time of the amount of oxygen dissolved in the blood (PaO2) in each of the three treatment groups: a control group (no apneic oxygenation), a 15 L/min group and a 60 L/min group. This data will help to determine the extent of benefit apneic oxygenation provides in this setting.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
These participants will receive 0 L/min oxygen via conventional nasal cannulae during the apneic period.
Drug: 0 L/min oxygen via conventional nasal cannulae
These participants will receive 15 L/min oxygen via conventional nasal cannulae during the apneic period.
Drug: 15 L/min oxygen via conventional nasal cannulae
These participants will receive 60 L/min oxygen via high-flow nasal cannulae during the apneic period.
Drug: 60 L/min oxygen via high-flow nasal cannulae
Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study.
Also known as: 0 L/min apneic oxygenation
Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 15 L/min of oxygen flowing through the cannulae in this group during the study.
Also known as: 15 L/min apneic oxygenation
Patients will have high-flow nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 60 L/min of oxygen flowing through the cannulae in this group during the study.
Also known as: 60 L/min apneic oxygenation
PaO2: repeated measures every 90 seconds after induction
data collected from serial arterial blood gas measurements
Time frame: 0-9 minutes after induction
Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction
data collected from serial arterial blood gas measurements
Time frame: 0-9 minutes after induction
Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study
continuous monitoring: data collected from electronic charting software
Time frame: 0-9 minutes after induction
Time to desaturation below 95% SpO2
continuous monitoring: data collected from electronic charting software
Time frame: 0-9 minutes after induction
Number of participants with SpO2 below 95%
continuous monitoring: data collected from electronic charting software
Time frame: 0-9 minutes after induction
Number of participants with sore throat
Data collected with PACU nurse questionnaire
Time frame: 1 hour post-operative or transfer out of post-anaesthesia care unit (PACU) if less than 1 hour post-operative
Number of participants with nausea
Data collected with PACU nurse questionnaire
Time frame: 1 hour post-operative or transfer out of PACU if less than 1 hour post-operative
Number of participants with epistaxis
Data collected with PACU nurse and staff anesthesiologist questionnaires
Time frame: 1 hour post-operative or transfer out of PACU if less than 1 hour post-operative
Number of participants with gastroesophageal regurgitation prior to endotracheal tube (ETT) placement
Data collected with staff anesthesiologist questionnaire
Time frame: Assessed at 90 seconds and 9 minutes after induction
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Nova Scotia Health Authority