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?



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:November 2016
End Date:November 2020
Contact:Curtis Baysinger, MD
Email:curtis.baysinger@Vanderbilt.Edu
Phone:(615) 322-8476

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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.

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.

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%.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Curtis Baysinger, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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