HypoxiaNCT00782977
Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
A study testing Nasal oxygen therapy in people with Hypoxia, run by University of Manitoba at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoxia
- What is being tested?
- Nasal oxygen therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Hypoxia
- Being tested
- Nasal oxygen therapy
- Keywords
- Apneic oxygenation, Apneic diffusion oxygenation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal oxygen therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Nasal cannulae with no oxygen flow Receives: Other: Nasal oxygen therapy |
| 2 | Active comparator | Nasal cannulae with oxygen flow at 5 L/minute Receives: Other: Nasal oxygen therapy |
| 3 | Active comparator | Nasal cannulae with oxygen flow at 10 L/minute Receives: Other: Nasal oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 in mmHg (arterial oxygen tension as measured by an arterial blood gas)
Measured: Arterial blood gases taken at one minute intervals post induction in the apneic period, for a total of 4 measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Chris Christodoulou, MBChB, FRCPC, Principal investigator, Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782977
- Sponsor's protocol ID
- B2008:129
- Status last verified
- May 2011
- First submitted
- 29 Oct 2008
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients
- ClinicalTrials.gov ID
- NCT00782977
- Acronym / sponsor ID
- B2008:129
- Conditions
- Hypoxia
- Keywords
- Apneic oxygenation, Apneic diffusion oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Other: Nasal oxygen therapyNasal cannulae with no oxygen flow |
| 2 | Active comparator | Other: Nasal oxygen therapyNasal cannulae with oxygen flow at 5 L/minute |
| 3 | Active comparator | Other: Nasal oxygen therapyNasal cannulae with oxygen flow at 10 L/minute |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal oxygen therapyArm 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 | Other | 1, 2, 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Christodoulou, MBChB, FRCPC principal investigator
Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal oxygen therapy in people with Hypoxia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.