Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Manitoba
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Winnipeg, Manitoba, Kanada, R2H 2A6
- St. Boniface General Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Schein-Komparator: 1
Nasal cannulae with no oxygen flow
|
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
|
|
Aktiver Komparator: 2
Nasal cannulae with oxygen flow at 5 L/minute
|
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
|
|
Aktiver Komparator: 3
Nasal cannulae with oxygen flow at 10 L/minute
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
PaO2 in mmHg (arterial oxygen tension as measured by an arterial blood gas)
Zeitfenster: Arterial blood gases taken at one minute intervals post induction in the apneic period, for a total of 4 measurements
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Arterial blood gases taken at one minute intervals post induction in the apneic period, for a total of 4 measurements
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Chris Christodoulou, MBChB, FRCPC, Dept of Anesthesia and Perioperative Medicine, St. Boniface General Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- B2008:129
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