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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-06-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Apneic Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0 L/min

These participants will receive 0 L/min oxygen via conventional nasal cannulae during the apneic period.

Group Type PLACEBO_COMPARATOR

0 L/min oxygen via conventional nasal cannulae

Intervention Type DRUG

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.

15 L/min

These participants will receive 15 L/min oxygen via conventional nasal cannulae during the apneic period.

Group Type EXPERIMENTAL

15 L/min oxygen via conventional nasal cannulae

Intervention Type DRUG

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.

60 L/min

These participants will receive 60 L/min oxygen via high-flow nasal cannulae during the apneic period.

Group Type EXPERIMENTAL

60 L/min oxygen via high-flow nasal cannulae

Intervention Type DRUG

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.

Interventions

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0 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.

Intervention Type DRUG

15 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.

Intervention Type DRUG

60 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.

Intervention Type DRUG

Other Intervention Names

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0 L/min apneic oxygenation 15 L/min apneic oxygenation 60 L/min apneic oxygenation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No