Back to resultsApneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasal oxygen therapy
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring Apneic oxygenation, Apneic diffusion oxygenation
Eligibility Criteria
Inclusion Criteria:
- Healthy males and females
- ASA Class 1-3
- Ages of 18 to 65
- Elective surgery under general anesthesia
- No evidence of significant cardiac, respiratory or gastrointestinal disease
- No contraindications to the insertion of a radial arterial catheter
Exclusion Criteria:
- Evidence of a difficult airway (expected difficult intubation identified from patient history or clinical examination)
- Features suggestive of difficult bag mask ventilation
- Significant GERD requiring medical therapy
- Significant respiratory disease (including severe asthma or COPD, oxygen dependency, pulmonary hypertension)
- Significant cardiac disease (ischemic heart disease, severe aortic and mitral stenosis and/or regurgitation, EF < 50% if known)
- Inability to lie flat (skeletal deformities, orthopnea, congestive cardiac failure)
- PaO2 < 200 mmHg on ABG after adequate preoxygenation to an ETO2 > 85%
- Hemoglobin < 100 g/L
- BMI > 40 kg/ m2
- Pregnancy
- Patient unwillingness or refusal to participate
- Inability to consent (dementia) or cooperate (mentally challenged)
- Inability to communicate well or to understand English (language barrier, dysphasia)
- Neuromuscular disorders
- Known or presumed cervical spine instability (cervical spine fractures, rheumatoid arthritis)
- Patients undergoing neurosurgical procedures
- Any clinical or radiological evidence of increase in intracranial pressure
- Any requirement for rapid sequence intubation
- Inability to tolerate the apneic period
- Allergy to any of the agents used for induction of general anesthesia in the study
- Arterial insufficiency with poor collateral circulation to the hand (tested with Doppler ultrasound or clinically by palpation with the Allen test)
- Inability to cannulate an artery for monitoring and sampling purposes
- Uncorrected coagulopathy
- Baseline hypercarbia (PaCO2 > 50 mmHg)
- Known or suspected obstructive sleep apnea
- Significant nasal obstruction
Sites / Locations
- St. Boniface General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Nasal cannulae with no oxygen flow
Nasal cannulae with oxygen flow at 5 L/minute
Nasal cannulae with oxygen flow at 10 L/minute
Outcomes
Primary Outcome Measures
PaO2 in mmHg (arterial oxygen tension as measured by an arterial blood gas)
Secondary Outcome Measures
Full Information
NCT ID
NCT00782977
First Posted
October 29, 2008
Last Updated
December 19, 2012
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT00782977
Brief Title
Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
Official Title
Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
Apneic oxygenation, Apneic diffusion oxygenation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
Nasal cannulae with no oxygen flow
Arm Title
2
Arm Type
Active Comparator
Arm Description
Nasal cannulae with oxygen flow at 5 L/minute
Arm Title
3
Arm Type
Active Comparator
Arm Description
Nasal cannulae with oxygen flow at 10 L/minute
Intervention Type
Other
Intervention Name(s)
Nasal oxygen therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy males and females
ASA Class 1-3
Ages of 18 to 65
Elective surgery under general anesthesia
No evidence of significant cardiac, respiratory or gastrointestinal disease
No contraindications to the insertion of a radial arterial catheter
Exclusion Criteria:
Evidence of a difficult airway (expected difficult intubation identified from patient history or clinical examination)
Features suggestive of difficult bag mask ventilation
Significant GERD requiring medical therapy
Significant respiratory disease (including severe asthma or COPD, oxygen dependency, pulmonary hypertension)
Significant cardiac disease (ischemic heart disease, severe aortic and mitral stenosis and/or regurgitation, EF < 50% if known)
Inability to lie flat (skeletal deformities, orthopnea, congestive cardiac failure)
PaO2 < 200 mmHg on ABG after adequate preoxygenation to an ETO2 > 85%
Hemoglobin < 100 g/L
BMI > 40 kg/ m2
Pregnancy
Patient unwillingness or refusal to participate
Inability to consent (dementia) or cooperate (mentally challenged)
Inability to communicate well or to understand English (language barrier, dysphasia)
Neuromuscular disorders
Known or presumed cervical spine instability (cervical spine fractures, rheumatoid arthritis)
Patients undergoing neurosurgical procedures
Any clinical or radiological evidence of increase in intracranial pressure
Any requirement for rapid sequence intubation
Inability to tolerate the apneic period
Allergy to any of the agents used for induction of general anesthesia in the study
Arterial insufficiency with poor collateral circulation to the hand (tested with Doppler ultrasound or clinically by palpation with the Allen test)
Inability to cannulate an artery for monitoring and sampling purposes
Uncorrected coagulopathy
Baseline hypercarbia (PaCO2 > 50 mmHg)
Known or suspected obstructive sleep apnea
Significant nasal obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Christodoulou, MBChB, FRCPC
Organizational Affiliation
Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
12. IPD Sharing Statement
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