Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

NCT00782977 | Completed

• 1 other identifier: B2008:129
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

Apneic oxygenation; Apneic diffusion oxygenation

Outcome Measures

Primary Outcomes (1)

• PaO2 in mmHg (arterial oxygen tension as measured by an arterial blood gas)

  Arterial blood gases taken at one minute intervals post induction in the apneic period, for a total of 4 measurements

Study Arms (3)

1

SHAM COMPARATOR

Nasal cannulae with no oxygen flow

Other: Nasal oxygen therapy

2

ACTIVE COMPARATOR

Nasal cannulae with oxygen flow at 5 L/minute

Other: Nasal oxygen therapy

3

ACTIVE COMPARATOR

Nasal cannulae with oxygen flow at 10 L/minute

Other: Nasal oxygen therapy

Interventions

Nasal oxygen therapy 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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Christodoulou, MBChB, FRCPC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2011-05

Locations

CA (1)