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CompletedNCT00782977Updated Dec 20, 2012

Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

An interventional study of Nasal oxygen therapy in Hypoxia, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-12-20.

Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the effectiveness of continuous oxygen provided by nasal prongs in preventing or delaying hypoxemia during the apneic period that occurs after induction of general anesthesia. This will be evaluated by measuring the arterial oxygen tension (PaO2).

The study will also evaluate whether there is any difference in PaO2 when using nasal prongs with flow rates of 5 L/minute versus 10 L/minute of oxygen.

Read the detailed description

Certain patient populations are at risk for rapid desaturation and the rapid development of hypoxemia (eg. morbidly obese and pregnant patients). Using pulse oximetry, it has already been shown that oxygen provided with a catheter inserted into the nasopharynx is effective in delaying the desaturation that occurs with apnea before the trachea is intubated. It has also been shown that apneic oxygenation with nasal prongs at 5 L/min during fibreoptic intubation can delay the onset of hypoxemia.

The study will evaluate whether there is any significant difference in the PaO2 (arterial oxygen tension, as measured by an arterial blood gas) when nasal prongs are used to provide apneic oxygenation in paralyzed patients at flows of 5 L/min compared to 10 L/min.

The study aims to demonstrate that apneic oxygenation using nasal prongs is effective in preventing or delaying hypoxemia (by measuring PaO2), and that this technique may be used to prevent morbidity and mortality in all clinical areas (not only in the Operating Room environment) where airway management is undertaken.

02

Conditions studied

  • Hypoxia

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Keywords

  • Apneic oxygenation
  • Apneic diffusion oxygenation
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 90 is above the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Healthy males and females
  2. ASA Class 1-3
  3. Ages of 18 to 65
  4. Elective surgery under general anesthesia
  5. No evidence of significant cardiac, respiratory or gastrointestinal disease
  6. No contraindications to the insertion of a radial arterial catheter

Exclusion criteria

Exclusion Criteria:

  1. Evidence of a difficult airway (expected difficult intubation identified from patient history or clinical examination)
  2. Features suggestive of difficult bag mask ventilation
  3. Significant GERD requiring medical therapy
  4. Significant respiratory disease (including severe asthma or COPD, oxygen dependency, pulmonary hypertension)
  5. Significant cardiac disease (ischemic heart disease, severe aortic and mitral stenosis and/or regurgitation, EF \< 50% if known)
  6. Inability to lie flat (skeletal deformities, orthopnea, congestive cardiac failure)
  7. PaO2 \< 200 mmHg on ABG after adequate preoxygenation to an ETO2 > 85%
  8. Hemoglobin \< 100 g/L
  9. BMI > 40 kg/ m2
  10. Pregnancy
  11. Patient unwillingness or refusal to participate
  12. Inability to consent (dementia) or cooperate (mentally challenged)
  13. Inability to communicate well or to understand English (language barrier, dysphasia)
  14. Neuromuscular disorders
  15. Known or presumed cervical spine instability (cervical spine fractures, rheumatoid arthritis)
  16. Patients undergoing neurosurgical procedures
  17. Any clinical or radiological evidence of increase in intracranial pressure
  18. Any requirement for rapid sequence intubation
  19. Inability to tolerate the apneic period
  20. Allergy to any of the agents used for induction of general anesthesia in the study
  21. Arterial insufficiency with poor collateral circulation to the hand (tested with Doppler ultrasound or clinically by palpation with the Allen test)
  22. Inability to cannulate an artery for monitoring and sampling purposes
  23. Uncorrected coagulopathy
  24. Baseline hypercarbia (PaCO2 > 50 mmHg)
  25. Known or suspected obstructive sleep apnea
  26. Significant nasal obstruction
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (estimated)

Study arms

  • Sham comparator
    1

    Nasal cannulae with no oxygen flow

    Other: Nasal oxygen therapy

  • Active comparator
    2

    Nasal cannulae with oxygen flow at 5 L/minute

    Other: Nasal oxygen therapy

  • Active comparator
    3

    Nasal cannulae with oxygen flow at 10 L/minute

    Other: Nasal oxygen therapy

Interventions

  • OtherNasal oxygen therapy

    Arm 1: Nasal cannulae with no oxygen flow. Arm 2: Nasal cannulae with oxygen flow at 5 L/min Arm 3: Nasal cannulae with oxygen flow at 10 L/min

06

What researchers measure

Primary outcomes

  1. PaO2 in mmHg (arterial oxygen tension as measured by an arterial blood gas)

    Time frame: Arterial blood gases taken at one minute intervals post induction in the apneic period, for a total of 4 measurements

07

Study locations

1 site
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H 2A6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00782977
Lead sponsor
University of Manitoba
First posted
Oct 31, 2008
Start date
Nov 2008
Primary completion
Nov 2012
Completion
Dec 2012
Last update
Dec 20, 2012

Study contacts

Chris Christodoulou, MBChB, FRCPC
principal investigator · Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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