NCT03775317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

December 11, 2018

Last Update Submit

March 14, 2019

Conditions

Intubation, Intratracheal

Keywords

Video laryngoscopyNasal intubation

Outcome Measures

Primary Outcomes (1)

  • success of first attempt intubation

    defined as confirmed placement of the endotracheal tube by bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak

    1 day

Secondary Outcomes (7)

  • amount of time required to secure the nasotracheal tube

    1 day

  • the use of Macgill forceps

    1 day

  • success at first attempt

    1 day

  • number of attempts

    1 day

  • number of endotracheal tube exchanges after placement

    1 day

  • +2 more secondary outcomes

Study Arms (2)

Video Laryngoscopy

EXPERIMENTAL
Procedure: Video Laryngoscopy

Direct Laryngoscopy

ACTIVE COMPARATOR
Procedure: Direct Laryngoscopy

Interventions

Video LaryngoscopyPROCEDURE

The direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx.

Video Laryngoscopy
Direct LaryngoscopyPROCEDURE

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.

Direct Laryngoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • prisoners
  • anticipated difficult airways

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

December 19, 2018

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)