Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia - Full Text View

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00782977

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients

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
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Sham Comparator 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
2: Active Comparator 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
3: Active Comparator 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:

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

Contacts and Locations

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

Contacts

Contact: Pam Rohald, MBBCh	(204) 237-2580	prohald@shaw.ca
Contact: Chris Christodoulou, MBChB, FRCPC	(204) 237-2580	chrischristodoulou@shaw.ca

Locations

Canada, Manitoba
St. Boniface General Hospital	Recruiting
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

Responsible Party:	Dept. of Anesthesia and Perioperative Medicine, St. Boniface General Hospital ( Dr Chris Christodoulou )
Study ID Numbers:	B2008:129
Study First Received:	October 29, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00782977
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

Apneic oxygenation
Apneic diffusion oxygenation

Study placed in the following topic categories:

Paralysis
Apnea

ClinicalTrials.gov processed this record on January 16, 2009