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Apneic Oxygenation Via Nasal Cannulae: 15 L/Min vs High-Flow

Apneic Oxygenation Via Nasal Cannulae: 15 L/Min vs High-Flow

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02755389
Enrollment
45
Registered
2016-04-28
Start date
2016-09-30
Completion date
2018-06-22
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apneic Oxygenation

Keywords

Tracheal intubation, High flow nasal oxygen, Airway management, Apneic oxygenation

Brief summary

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.

Detailed description

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.

Interventions

DRUG0 L/min oxygen via conventional 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.

DRUG15 L/min oxygen via conventional 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 15 L/min of oxygen flowing through the cannulae in this group during the study.

DRUG60 L/min oxygen via high-flow nasal cannulae

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.

Sponsors

Dalhousie University
CollaboratorOTHER
Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists Physical Status Classification 1 to 3 * Body Mass Index 28 to 35 * Elective surgery under general anesthesia

Exclusion criteria

* Evidence of difficult airway management (from patient history or clinical examination) * Features suggestive of difficult bag mask ventilation * Significant uncontrolled gastroesophageal reflux disease * Significant respiratory disease (including severe asthma or chronic obstructive pulmonary disease, oxygen dependency, pulmonary hypertension, identified by pulmonary function tests or inability to climb one flight of stairs) * Significant cardiac disease (ischemic heart disease, severe valvular disease, severe arrhythmia, congestive heart failure, ejection fraction \< 50%, inability to climb one flight of stairs) * Inability to lie flat (skeletal deformities, orthopnea) * Hemoglobin \< 100 g/L * Pregnancy * Neuromuscular disorder * Known or suspected cervical spine instability * Patients undergoing neurosurgical procedures * Any clinical or radiological evidence of increased intracranial pressure * Any expected requirement for rapid sequence intubation * Allergy to any of the agents used for induction of general anesthesia in the study * Contraindication to insertion of radial artery cannula * Uncorrected coagulopathy * Significant nasal obstruction

Design outcomes

Primary

MeasureTime frameDescription
PaO2: repeated measures every 90 seconds after induction0-9 minutes after inductiondata collected from serial arterial blood gas measurements

Secondary

MeasureTime frameDescription
Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction0-9 minutes after inductiondata collected from serial arterial blood gas measurements
Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study0-9 minutes after inductioncontinuous monitoring: data collected from electronic charting software
Time to desaturation below 95% SpO20-9 minutes after inductioncontinuous monitoring: data collected from electronic charting software
Number of participants with SpO2 below 95%0-9 minutes after inductioncontinuous monitoring: data collected from electronic charting software

Other

MeasureTime frameDescription
Number of participants with nausea1 hour post-operative or transfer out of PACU if less than 1 hour post-operativeData collected with PACU nurse questionnaire
Number of participants with epistaxis1 hour post-operative or transfer out of PACU if less than 1 hour post-operativeData collected with PACU nurse and staff anesthesiologist questionnaires
Number of participants with gastroesophageal regurgitation prior to endotracheal tube (ETT) placementAssessed at 90 seconds and 9 minutes after inductionData collected with staff anesthesiologist questionnaire
Number of participants with sore throat1 hour post-operative or transfer out of post-anaesthesia care unit (PACU) if less than 1 hour post-operativeData collected with PACU nurse questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026