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?

NCT02943629 | Withdrawn

• 1 other identifier: 160579
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Apneic Oxygenation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Non-Obese: Apneic Oxygenation: eight minute

EXPERIMENTAL

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%.

Device: Apneic oxygenation: Eight minute

Non-Obese: Without Apneic Oxygenation

OTHER

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%.

Device: Without apneic oxygenation

Obese: Apneic Oxygenation: five minute

EXPERIMENTAL

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%.

Device: Apneic oxygenation: five minutes

Obese: Without Apneic Oxygenation

OTHER

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%.

Device: Without apneic oxygenation

Interventions

Apneic oxygenation: Eight minute DEVICE

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%.

Non-Obese: Apneic Oxygenation: eight minute

Without apneic oxygenation DEVICE

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%.

Non-Obese: Without Apneic Oxygenation; Obese: Without Apneic Oxygenation

Apneic oxygenation: five minutes DEVICE

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%.

Obese: Apneic Oxygenation: five minute

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead

Related Publications (28)

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Study Officials

• Curtis Baysinger, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 25, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share