Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

NCT ID: NCT03032263

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-08-07

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.

Detailed Description

The objective of this study is to compare the need for the use of standard Magill forceps when performing a nasal intubation with either conventional DL or VL with a C-Mac. Secondarily the investigators will also examine the time to intubate (TTI) for both methods as well.

Once the patient is recruited, the patient will then be randomized to either intubation using DL or VL with a C-Mac. Once the patient is under anesthesia, the intubation will be performed by an attending pediatric anesthesiologist or experience pediatric CRNA who has experience both DL and with the C-Mac and will attempt to intubate the patient with or without Magill forceps as needed.

The investigators will record the time to intubation (TTI) from the time the laryngoscope or C-Mac is placed in the mouth to the first appearance of end tidal carbon dioxide (ETCO2). the investigators will record the presence or absence of nasal bleeding, and the grade of laryngeal view. The investigators will also record any general narrative comments about the ease or difficulty of intubation in both groups.

The study will be performed at Wake Forest Baptist Medical Center.

Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under general anesthesia will be included.

Normal appearing airway upon pre-operative assessment. The investigators have calculated a sample size of 35 patients in each group to be able to detect a significant difference in the rate of use of Magill forceps to place a nasal RAE ETT in this patient population.

Conditions

Nasal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Direct Laryngoscopy

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.

Group Type: ACTIVE_COMPARATOR

Direct Laryngoscopy

Intervention Type: DEVICE

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

Video Laryngoscopy

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.

Group Type: EXPERIMENTAL

Video Laryngoscopy for nasal intubation

Intervention Type: DEVICE

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

Interventions

Video Laryngoscopy for nasal intubation

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

Intervention Type: DEVICE

Direct Laryngoscopy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas W Templeton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24958249 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21244568 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18635480 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CMac-032016

Identifier Type: -

Identifier Source: org_study_id