Clinical trial NCT02943629: A "Less-rapid" Sequence Anesthetic Induction/Intubation Sequence? Does Apneic Oxygenation by Means of an Oxygenating Laryngoscope Blade Prolong the "Duration of Apnea Without Desaturation" in Paralyzed Non-obese and Morbidly Obese Patients?
Official title: A "Less-rapid" Sequence Anesthetic Induction/Intubation Sequence? Does Apneic Oxygenation by Means of an Oxygenating Laryngoscope Blade Prolong the "Duration of Apnea Without Desaturation" in Paralyzed Non-obese and Morbidly Obese Patients?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Apneic Oxygenation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.

Detailed description: Pre-oxygenation/de-nitrogenation for three minutes of spontaneous breathing or alternatively four to eight deep breaths prior to rapid sequence anesthetic induction/intubation (RSII) in patients with healthy lungs, low oxygen demands and normal hemoglobin levels allows up to eight minutes of safe apnea time or DAWD.

The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade as the means to provide apneic oxygenation and prolong DAWD. The P Blade sports a suction conduit which can equally well provide a conduit for oxygen administration. The initial phase of the study will include non-obese healthy (ASAR 1-2) women patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery. Subsequently a cohort of morbidly obese patients (BM I ≥ 40 kg/m2) also requiring gynecologic abdominal access will be recruited for investigation.

Participants of each group (obese, non-obese) will be randomized to apneic oxygenation with the the Pentax AWS Laryngoscope or no apneic oxygenation.

Eligibility criteria: Inclusion Criteria:

1. Female patients,
2. American Society of Anesthesiologists Rating 1-2,
3. Aged 18 through 65 years of age
4. Elective gynecological surgery via an abdominal approach (laparoscopic or open)
5. Already consented to general anesthesia necessitating endotracheal intubation.
6. Are candidates for anesthesia using laryngeal mask airway if needed

Exclusion Criteria:

1. Patient refusal to enter study
2. History of difficult mask ventilation
3. History of, or anticipated difficult intubation
4. Heavy Smokers (\> 10 cigarettes per day)
5. Asthma
6. Chronic Obstructive Pulmonary Disease
7. Heart Disease
8. Renal or Liver disease
9. Neurological disease.
10. Women scored at ≥ 3/4 on the modified Mallampati scale 30.
11. Women exhibiting other signs of a potential difficult intubation (limited neck flexion or extension; neck circumference \> 30 cm; prominent incisors)
12. Patients with a baseline resting oxygenation level of less than 95%.

Primary outcomes:
measure: Duration of apnea without desaturation
timeFrame: Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Curtis Baysinger, MD
role: PRINCIPAL_INVESTIGATOR
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