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Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Surgery (MASK)

This study is currently recruiting participants.
Verified January 2017 by Rainer Lenhardt, University of Louisville
Sponsor:
ClinicalTrials.gov Identifier:
NCT02018146
First Posted: December 23, 2013
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville
  Purpose

Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask ventilation allowing for better oxygenation during the induction phase of general anesthesia. Oxygenation may be maintained better in case of difficult mask ventilation. This study evaluates this alternative method in comparison with the standard method of mask ventilation.

General Design This is a randomized, controlled, cross over study. Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or vice versa.

Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed ETT is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in patients undergoing general anesthesia and endotracheal intubation for their surgery.


Condition Intervention
General Anesthesia With Endotracheal Intubation in Surgery Other: Mask then nasopharyngeal Other: Nasopharyngeal then mask

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Patients With Predicted Difficult to Mask Ventilate

Further study details as provided by Rainer Lenhardt, University of Louisville:

Primary Outcome Measures:
  • Tidal volume [ Time Frame: 15 minutes ]
    After facemask or nasopharyngeal ventilation


Secondary Outcome Measures:
  • Airway pressure [ Time Frame: 3 min after facemask or nasopharyngeal ventilation ]

Estimated Enrollment: 20
Study Start Date: June 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nasopharyngeal then mask
Patients will be randomized to nasopharyngeal airway placement and ventilation followed by mask ventilation
Other: Nasopharyngeal then mask
Patients will be randomly assigned to naso-pharyngeal ventilation followed by mask ventilation.
Mask then nasopharyngeal
Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation
Other: Mask then nasopharyngeal
Patients will be randomly assigned to Mask ventilation followed by naso-pharyngeal ventilation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects undergoing general anesthesia and require endotracheal intubation.
  2. Adults patients 18 years or greater
  3. Subjects are capable of understanding and signing the Informed Consent Form or have an acceptable representative capable of giving legally authorized consent on their behalf.
  4. Meet three or more of predictive difficult to mask criteria as listed:

    1. Age = or > than 55
    2. BMI = or > than 30
    3. Edentulism
    4. History of snoring and/or a diagnoses of obstructive sleep apnea
    5. STOP/BANG score of three or greater
    6. Presesnce or a beard or mustach that covers the part of the face in conntact with the facemask edges
    7. Male gender
    8. History of neck radiation
    9. Mallampati score of III or IV

Exclusion Criteria:

  • Subjects will be excluded from this study in cases where there will not be an attempt at mask ventilation. This includes patients that will require an awake fiberoptic intubation as well as those needing a rapid sequence intubation.
  • Subjects with full stomachs, known hiatal hernia, and severe gastroesophageal reflux will be excluded.
  • Subjects with known or suspected basilar skull fractures will be excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018146


Contacts
Contact: Rainer Lenhardt, MD 502-852-3122 rainer.lenhardt@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Elizabeth Cooke, RN    502-852-5851    eacook02@louisville.edu   
Principal Investigator: Rainer Lenhardt, M.D.         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Rainer Lenhardt, MD University of Louisville School of Medicine
  More Information

Publications:
Responsible Party: Rainer Lenhardt, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02018146     History of Changes
Other Study ID Numbers: 13.0570
First Submitted: October 29, 2013
First Posted: December 23, 2013
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by Rainer Lenhardt, University of Louisville:
Laryngeal Masks
Airway Management