Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00782977
First received: October 29, 2008
Last updated: December 19, 2012
Last verified: May 2011
  Purpose

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.


Condition Intervention
Hypoxia
Other: Nasal oxygen therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: November 2008
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
Nasal cannulae with no oxygen flow
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
Active Comparator: 2
Nasal cannulae with oxygen flow at 5 L/minute
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
Active Comparator: 3
Nasal cannulae with oxygen flow at 10 L/minute
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782977

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Chris Christodoulou, MBChB, FRCPC Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
  More Information

No publications provided

Responsible Party: Dr Chris Christodoulou, Dept. of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
ClinicalTrials.gov Identifier: NCT00782977     History of Changes
Other Study ID Numbers: B2008:129
Study First Received: October 29, 2008
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Apneic oxygenation
Apneic diffusion oxygenation

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014