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Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

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ClinicalTrials.gov Identifier: NCT00782977
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : December 20, 2012
Sponsor:
Information provided by:
University of Manitoba

October 29, 2008
October 31, 2008
December 20, 2012
November 2008
November 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00782977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Hypoxia
Other: Nasal 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
  • Sham Comparator: 1
    Nasal cannulae with no oxygen flow
    Intervention: Other: Nasal oxygen therapy
  • Active Comparator: 2
    Nasal cannulae with oxygen flow at 5 L/minute
    Intervention: Other: Nasal oxygen therapy
  • Active Comparator: 3
    Nasal cannulae with oxygen flow at 10 L/minute
    Intervention: Other: Nasal oxygen therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Same as current
December 2012
November 2012   (Final data collection date for primary outcome measure)

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:

  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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00782977
B2008:129
No
Not Provided
Not Provided
Dr Chris Christodoulou, Dept. of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
University of Manitoba
Not Provided
Principal Investigator: Chris Christodoulou, MBChB, FRCPC Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
University of Manitoba
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP