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?

Vanderbilt University

Status: Withdrawn

Conditions: Apneic Oxygenation

Treatments: Device: Without apneic oxygenation; Device: Apneic oxygenation: Eight minute; Device: Apneic oxygenation: five minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT02943629

160579

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Non-Obese: Apneic Oxygenation: eight minute

Experimental group

Description:

Non-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.

Treatment:

Device: Apneic oxygenation: Eight minute

Non-Obese: Without Apneic Oxygenation

Other group

Description:

Non-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.

Treatment:

Device: Without apneic oxygenation

Obese: Apneic Oxygenation: five minute

Experimental group

Description:

Morbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.

Treatment:

Device: Apneic oxygenation: five minutes

Obese: Without Apneic Oxygenation

Other group

Description:

Morbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.

Treatment:

Device: Without apneic oxygenation