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?

Apneic Oxygenation Clinical Trial

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?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02943629
• Other study ID #: 160579
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Apnea
• Apneic Oxygenation

Intervention

Device:
• Apneic oxygenation: Eight minute
A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for eight minutes, or less 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%.
• Without apneic oxygenation
A Pentax AWSTM video laryngoscope with attached P blade will be placed for eight minutes, or less 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%.
• Apneic oxygenation: five minutes
A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for five minutes, or less 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%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of apnea without desaturation		Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed