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Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

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.
 
ClinicalTrials.gov Identifier: NCT03775317
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Brett King, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
Nasotracheal intubation is a common method for securing an advanced airway during surgery for procedures that involve manipulation of the oral cavity, the dentition, or the facial bones. The placement of a nasotracheal tube is often more challenging, especially for learning providers, even for patients with normal airway anatomy. Video laryngoscopy is an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade and provides an indirect view of the glottis during intubation through display on a monitor. The use of video laryngoscopes has been shown to reduce time to intubation, result in perception of easier intubation by the anesthesia team, and reduce the use of adjunctive maneuvers during intubation. There is little evidence, however, to show these benefits for routine nasotracheal intubation. The purpose of the study is to compare the ease of video-assisted laryngoscopy and direct laryngoscopy in routine nasotracheal intubation for Maxillofacial procedures. The investigators hypothesize that the use of video-assisted laryngoscopy for routine nasotracheal intubation will result in quicker time to intubation, less adjunctive maneuvers and anesthesia perception of easier intubation when compared to direct nasotrahceal intubation. The investigators aim to compare the time to intubation, number of adjunctive maneuvers and the perception of intubation difficulty in routine nasotracheal intubation for Maxillofacial procedures for video-assisted laryngoscopy and direct laryngoscopy.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Procedure: Video Laryngoscopy Procedure: Direct Laryngoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Video-assisted Laryngoscopy and Direct Laryngoscopy for Routine Nasotracheal Intubation in Oral and Maxillofacial Surgery Patients: a Randomized Controlled Trial.
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Video Laryngoscopy Procedure: Video Laryngoscopy
The direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx.

Active Comparator: Direct Laryngoscopy Procedure: Direct Laryngoscopy
The video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.




Primary Outcome Measures :
  1. success of first attempt intubation [ Time Frame: 1 day ]
    defined as confirmed placement of the endotracheal tube by bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak


Secondary Outcome Measures :
  1. amount of time required to secure the nasotracheal tube [ Time Frame: 1 day ]
    amount of time required to secure the nasotracheal tube

  2. the use of Macgill forceps [ Time Frame: 1 day ]
    the use of Macgill forceps

  3. success at first attempt [ Time Frame: 1 day ]
    success at first attempt

  4. number of attempts [ Time Frame: 1 day ]
    number of attempts

  5. number of endotracheal tube exchanges after placement [ Time Frame: 1 day ]
    number of endotracheal tube exchanges after placement

  6. number of torn endotracheal tube cuffs [ Time Frame: 1 day ]
    number of torn endotracheal tube cuffs

  7. Cormack-Lehane score [ Time Frame: 1 day ]
    Cormack-Lehane score



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

Inclusion Criteria:

  • oral and maxillofacial surgery to be performed under general anesthesia
  • planned for a general anesthetic with nasotracheal intubation,
  • ASA I and II
  • at least 18 years of age

Exclusion Criteria:

  • prisoners
  • anticipated difficult airways

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): NCT03775317


Locations
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United States, Louisiana
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Brett J King, DDS    504-702-2000    bking6@lsuhsc.edu   
Principal Investigator: Brett J King, DDS         
Sub-Investigator: Brian J Christensen, DDS, MD         
Sub-Investigator: Ira Padnos, MD         
Sub-Investigator: Kenneth Mancuso, MD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
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Responsible Party: Brett King, Assistant Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03775317    
Other Study ID Numbers: 10272
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brett King, Louisiana State University Health Sciences Center in New Orleans:
Video laryngoscopy
Nasal intubation