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

NCT02755389 | Completed Phase 4

• 1 other identifier: CapitalDHACanada
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Apneic Oxygenation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PaO2: repeated measures every 90 seconds after induction

  data collected from serial arterial blood gas measurements

  0-9 minutes after induction

Secondary Outcomes (4)

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

  0-9 minutes after induction

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

  0-9 minutes after induction

• Time to desaturation below 95% SpO2

  0-9 minutes after induction

• Number of participants with SpO2 below 95%

  0-9 minutes after induction

Other Outcomes (4)

• Number of participants with sore throat

  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

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

• Number of participants with epistaxis

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

Study Arms (3)

0 L/min

PLACEBO COMPARATOR

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

15 L/min

EXPERIMENTAL

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

60 L/min

EXPERIMENTAL

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

Interventions

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.

Also known as: 0 L/min apneic oxygenation

0 L/min

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.

Also known as: 15 L/min apneic oxygenation

15 L/min

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.

Also known as: 60 L/min apneic oxygenation

60 L/min

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (1)

Halifax Infirmary, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (3)

• 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.

  PMID: 25388828 BACKGROUND

• 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.

  PMID: 20400000 BACKGROUND

• 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

  BACKGROUND

Study Officials

• Tim Mullen, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2016
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)