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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?

Primary Purpose

Apneic Oxygenation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apneic oxygenation: Eight minute
Without apneic oxygenation
Apneic oxygenation: five minutes
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apneic Oxygenation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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%.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Other

    Experimental

    Other

    Arm Label

    Non-Obese: Apneic Oxygenation: eight minute

    Non-Obese: Without Apneic Oxygenation

    Obese: Apneic Oxygenation: five minute

    Obese: Without Apneic Oxygenation

    Arm 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%.

    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%.

    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%.

    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%.

    Outcomes

    Primary Outcome Measures

    Duration of apnea without desaturation

    Secondary Outcome Measures

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    May 6, 2019
    Sponsor
    Vanderbilt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02943629
    Brief 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?
    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

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of feasibility
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    April 1, 2019 (Actual)
    Study Completion Date
    April 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apneic Oxygenation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Obese: Apneic Oxygenation: eight minute
    Arm Type
    Experimental
    Arm 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%.
    Arm Title
    Non-Obese: Without Apneic Oxygenation
    Arm Type
    Other
    Arm 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%.
    Arm Title
    Obese: Apneic Oxygenation: five minute
    Arm Type
    Experimental
    Arm 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%.
    Arm Title
    Obese: Without Apneic Oxygenation
    Arm Type
    Other
    Arm 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%.
    Intervention Type
    Device
    Intervention Name(s)
    Apneic oxygenation: Eight minute
    Intervention Description
    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%.
    Intervention Type
    Device
    Intervention Name(s)
    Without apneic oxygenation
    Intervention Description
    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%.
    Intervention Type
    Device
    Intervention Name(s)
    Apneic oxygenation: five minutes
    Intervention Description
    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%.
    Primary Outcome Measure Information:
    Title
    Duration of apnea without desaturation
    Time Frame
    Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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%.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Curtis Baysinger, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    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?

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