Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

Nasal Intubation Clinical Trial

Official title:

A Comparison of Direct Laryngoscopy and Video Laryngoscopy Using the C-Mac in Pediatric Nasal Intubations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03032263
• Other study ID #: CMac-032016
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 7, 2017

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Intubation

Intervention

Device:
• Video Laryngoscopy for nasal intubation
The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
• Direct Laryngoscopy
These patients will be nasally intubated for their procedure via direct laryngoscopy

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope(®) 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Intubation	Reported as the average time it took to intubate (seconds).	1 day
Secondary	Grade of Larynx View	Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).	1 day
Secondary	Presence of Nasal Bleeding	Number of participants that experienced nasal bleeding was recorded.	1 day
Secondary	Incidence of Failed Nasal Intubation	The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.	1 day