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.

Study Overview

• Status: Completed
• Conditions: Apneic Oxygenation
• Intervention / Treatment: Drug: 0 L/min oxygen via conventional nasal cannulae; Drug: 15 L/min oxygen via conventional nasal cannulae; Drug: 60 L/min oxygen via high-flow nasal cannulae

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Halifax Infirmary, QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0 L/min; 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; 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
Experimental: 15 L/min; 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; 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
Experimental: 60 L/min; 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2: repeated measures every 90 seconds after induction	data collected from serial arterial blood gas measurements	0-9 minutes after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction	data collected from serial arterial blood gas measurements	0-9 minutes after induction
Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study	continuous monitoring: data collected from electronic charting software	0-9 minutes after induction
Time to desaturation below 95% SpO2	continuous monitoring: data collected from electronic charting software	0-9 minutes after induction
Number of participants with SpO2 below 95%	continuous monitoring: data collected from electronic charting software	0-9 minutes after induction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with sore throat	Data collected with PACU nurse questionnaire	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	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	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	Assessed at 90 seconds and 9 minutes after induction

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Dalhousie University
• Investigators: Principal Investigator: Tim Mullen, MD, Nova Scotia Health Authority

Publications and helpful links

General Publications

• Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
• Christodoulou C, Rohald P, Mullen T. (2013). Apneic oxygenation via nasal prongs at 10 L/min prevents hypoxemia during tracheal intubation for elective surgery. European Respiratory Society Annual Congress 2013. Abstract Number: 5356 Publication Number: P4923

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 22, 2018

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: High flow nasal oxygen; Tracheal intubation; Airway management; Apneic oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: CapitalDHACanada

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO