Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

NCT ID: NCT00782977

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Hypoxia

Keywords

Apneic oxygenation; Apneic diffusion oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Nasal cannulae with no oxygen flow

Group Type: SHAM_COMPARATOR

Nasal oxygen therapy

Intervention Type: OTHER

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

2

Nasal cannulae with oxygen flow at 5 L/minute

Group Type: ACTIVE_COMPARATOR

Nasal oxygen therapy

Intervention Type: OTHER

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

3

Nasal cannulae with oxygen flow at 10 L/minute

Group Type: ACTIVE_COMPARATOR

Nasal oxygen therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Anesthesia and Perioperative Medicine, St. Boniface General Hospital

Principal Investigators

Chris Christodoulou, MBChB, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital

Locations

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2008:129

Identifier Type: -

Identifier Source: org_study_id