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Completed

NCT Number: NCT02755389

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

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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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Halifax Infirmary, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0 L/min oxygen via conventional nasal cannulae

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.

Other names: 0 L/min apneic oxygenation

15 L/min oxygen via conventional nasal cannulae

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.

Other names: 15 L/min apneic oxygenation

60 L/min oxygen via high-flow nasal cannulae

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.

Other names: 60 L/min apneic oxygenation

Primary outcomes

  1. PaO2: repeated measures every 90 seconds after induction

    Time frame: 0-9 minutes after induction

    data collected from serial arterial blood gas measurements

Secondary outcomes

  1. Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction

    Time frame: 0-9 minutes after induction

    data collected from serial arterial blood gas measurements

  2. Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study

    Time frame: 0-9 minutes after induction

    continuous monitoring: data collected from electronic charting software

  3. Time to desaturation below 95% SpO2

    Time frame: 0-9 minutes after induction

    continuous monitoring: data collected from electronic charting software

  4. Number of participants with SpO2 below 95%

    Time frame: 0-9 minutes after induction

    continuous monitoring: data collected from electronic charting software

Other outcomes

  1. Number of participants with sore throat

    Time frame: 1 hour post-operative or transfer out of post-anaesthesia care unit (PACU) if less than 1 hour post-operative

    Data collected with PACU nurse questionnaire

  2. Number of participants with nausea

    Time frame: 1 hour post-operative or transfer out of PACU if less than 1 hour post-operative

    Data collected with PACU nurse questionnaire

  3. Number of participants with epistaxis

    Time frame: 1 hour post-operative or transfer out of PACU if less than 1 hour post-operative

    Data collected with PACU nurse and staff anesthesiologist questionnaires

  4. Number of participants with gastroesophageal regurgitation prior to endotracheal tube (ETT) placement

    Time frame: Assessed at 90 seconds and 9 minutes after induction

    Data collected with staff anesthesiologist questionnaire

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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