Skip to main content
OpenTrials
Completed

NCT Number: NCT00782977

Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia During the Apneic Period in Paralyzed Patients

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2008
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.