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

Primary Purpose

Apneic Oxygenation

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

0 L/min oxygen via conventional nasal cannulae

15 L/min oxygen via conventional nasal cannulae

60 L/min oxygen via high-flow nasal cannulae

About this trial

This is an interventional treatment trial for Apneic Oxygenation focused on measuring Tracheal intubation, High flow nasal oxygen, Airway management, Apneic oxygenation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Halifax Infirmary, QEII Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

0 L/min

15 L/min

60 L/min

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

PaO2: repeated measures every 90 seconds after induction

data collected from serial arterial blood gas measurements

Secondary Outcome Measures

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

data collected from serial arterial blood gas measurements

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

continuous monitoring: data collected from electronic charting software

Time to desaturation below 95% SpO2

continuous monitoring: data collected from electronic charting software

Number of participants with SpO2 below 95%

continuous monitoring: data collected from electronic charting software

Full Information

NCT ID

NCT02755389

First Posted

April 25, 2016

Last Updated

June 26, 2018

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

1. Study Identification

Unique Protocol Identification Number

NCT02755389

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

June 22, 2018 (Actual)

Study Completion Date

June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apneic Oxygenation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0 L/min

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

15 L/min

Arm Type

Experimental

Arm Description

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

Arm Title

60 L/min

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0 L/min oxygen via conventional nasal cannulae

Other Intervention Name(s)

0 L/min apneic oxygenation

Intervention Description

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

Intervention Name(s)

15 L/min oxygen via conventional nasal cannulae

Other Intervention Name(s)

15 L/min apneic oxygenation

Intervention Description

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

Intervention Name(s)

60 L/min oxygen via high-flow nasal cannulae

Other Intervention Name(s)

60 L/min apneic oxygenation

Intervention Description

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.

Primary Outcome Measure Information:

Title

PaO2: repeated measures every 90 seconds after induction

Description

data collected from serial arterial blood gas measurements

Time Frame

0-9 minutes after induction

Secondary Outcome Measure Information:

Title

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

Description

data collected from serial arterial blood gas measurements

Time Frame

0-9 minutes after induction

Title

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

Description

continuous monitoring: data collected from electronic charting software

Time Frame

0-9 minutes after induction

Title

Time to desaturation below 95% SpO2

Description

continuous monitoring: data collected from electronic charting software

Time Frame

0-9 minutes after induction

Title

Number of participants with SpO2 below 95%

Description

continuous monitoring: data collected from electronic charting software

Time Frame

0-9 minutes after induction

Other Pre-specified Outcome Measures:

Title

Number of participants with sore throat

Description

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

Title

Number of participants with nausea

Description

Data collected with PACU nurse questionnaire

Time Frame

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

Title

Number of participants with epistaxis

Description

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

Title

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

Description

Data collected with staff anesthesiologist questionnaire

Time Frame

Assessed at 90 seconds and 9 minutes after induction

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Mullen, MD

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Principal Investigator

Facility Information:

Facility Name

Halifax Infirmary, QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25388828

Citation

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.

Results Reference

background

PubMed Identifier

20400000

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

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

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