Clincosm LogoSign in Get a demo

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?

Sponsor
Vanderbilt University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02943629
Collaborator
(none)
0
Enrollment
4
Arms
28.9
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Apneic oxygenation: Eight minute
  • Device: Without apneic oxygenation
  • Device: Apneic oxygenation: five minutes
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non-Obese: Apneic Oxygenation: eight minute

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
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%.
Other: Non-Obese: Without Apneic Oxygenation

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
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%.
Experimental: Obese: Apneic Oxygenation: five minute

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
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%.
Other: Obese: Without Apneic Oxygenation

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
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%.

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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%.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vanderbilt University

Investigators

  • Principal Investigator: Curtis Baysinger, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Curtis Baysinger, Professor of Anesthesiology, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02943629
Other Study ID Numbers:
  • 160579
First Posted:
Oct 25, 2016
Last Update Posted:
May 8, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Apnea

Study Results

No Results Posted as of May 8, 2019