Trial record 9 of 2881 for:    Open Studies | "General Surgery"

Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Otolaryngologic and Oral Maxillofacial Surgery (MASK)

This study is not yet open for participant recruitment.
Verified December 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville
ClinicalTrials.gov Identifier:
NCT02018146
First received: October 29, 2013
Last updated: December 16, 2013
Last verified: December 2013
  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 oto-laryngologic or oral maxillofacial surgery that requires nasal intubation.


Condition Intervention
Oto-laryngeal Surgery
Maxillo-facial Surgery
Other: Mask then nasopharyngeal
Other: Nasopharyngeal then mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Otolaryngologic and Oral Maxillofacial Surgery

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Tidal volume [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    After facemask or nasopharyngeal ventilation


Secondary Outcome Measures:
  • Airway pressure [ Time Frame: 3 min after facemask or nasopharyngeal ventilation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nasopharyngeal then mask
Patients will be randomized to nasopharyngeal airway placement 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
Other: Mask then nasopharyngeal
Patients will be randomly assigned to Mask ventilation followed by naso-pharyngeal ventilation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects undergoing any elective oto-laryngeal or maxillo-facial surgery requiring nasal intubation
  • Adult patients 18 years of age or older
  • Subjects are capable of understanding and signing the Informed Consent Form or have an acceptable representative capable of giving legally authorized consent on the subject's behalf.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02018146

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

Locations
United States, Kentucky
University of Louisville Not yet 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

No publications provided

Responsible Party: Rainer Lenhardt, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02018146     History of Changes
Other Study ID Numbers: 13.0570
Study First Received: October 29, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Laryngeal Masks
Airway Management

ClinicalTrials.gov processed this record on April 16, 2014