Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

NCT03032263 | Terminated Results

• 1 other identifier: CMac-032016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward toward the forehead. This unique shape ensures that the tube will not interfere with surgical exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is possible without an adjuvant, but frequently a pair of specially shaped forceps, known as Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to the curvature of these ETT. Magill forceps are introduced into the mouth and are used to grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the current literature suggests, it has been our experience that nasal intubations using the C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This technique may improve the time and ease to intubation because of not having to use the Magill forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization due to obstruction of the view by this tool in the airway, and small working space within the posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps because the investigators are using a C-Mac as the only tool to intubate is a potentially inviting one.

Conditions

Nasal Intubation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Requiring Use of Magill Forceps for Nasal Intubations

  Reported as the number and percentage of participants that needed the use of Magill forceps during intubation

  1 day

Secondary Outcomes (4)

• Time to Intubation

  1 day

• Grade of Larynx View

  1 day

• Presence of Nasal Bleeding

  1 day

• Incidence of Failed Nasal Intubation

  1 day

Study Arms (2)

Direct Laryngoscopy

ACTIVE COMPARATOR

These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.

Device: Direct Laryngoscopy

Video Laryngoscopy

EXPERIMENTAL

These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.

Device: Video Laryngoscopy for nasal intubation

Interventions

Video Laryngoscopy for nasal intubation DEVICE

The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.

Video Laryngoscopy

Direct Laryngoscopy DEVICE

These patients will be nasally intubated for their procedure via direct laryngoscopy

Direct Laryngoscopy

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under general anesthesia
• Normal appearing airway upon pre-operative assessment

You may not qualify if:

• Patient with a history of difficult airway/intubation
• Patients suspected to have a difficult airway
• History of cleft palate and/or cleft palate repair
• Pregnancy
• Emergency status of surgery
• Any patient with a contra-indication to nasal tube placement
• Any patient with a potentially increased risk of nasal bleeding from nasal placement of the ETT i.e. patients on aspirin or other anticoagulants, patient's with hemophilia

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• Sun Y, Lu Y, Huang Y, Jiang H. Pediatric video laryngoscope versus direct laryngoscope: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Oct;24(10):1056-65. doi: 10.1111/pan.12458. Epub 2014 Jun 24.

  PMID: 24958249 BACKGROUND

• Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.

  PMID: 21244568 RESULT

• Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9.

  PMID: 18635480 RESULT

Results Point of Contact

• Title: Dr. Thomas Templeton
• Organization: Wake Forest University Health Sciences

ttemplet@wakehealth.edu

336-716-4285

Study Officials

• Thomas W Templeton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 26, 2017
• Study Start: March 1, 2016
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: August 8, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)