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Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

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ClinicalTrials.gov Identifier: NCT03032263
Recruitment Status : Terminated (Not enough participants enrolled)
First Posted : January 26, 2017
Results First Posted : July 11, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Nasal Intubation Device: Video Laryngoscopy for nasal intubation Device: Direct Laryngoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Comparison of Direct Laryngoscopy and Video Laryngoscopy Using the C-Mac in Pediatric Nasal Intubations
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 7, 2017
Actual Study Completion Date : August 7, 2017

Arm Intervention/treatment
Active Comparator: 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.
Device: Direct Laryngoscopy
These patients will be nasally intubated for their procedure via direct laryngoscopy

Experimental: 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.
Device: Video Laryngoscopy for nasal intubation
The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.




Primary Outcome Measures :
  1. Number of Participants Requiring Use of Magill Forceps for Nasal Intubations [ Time Frame: 1 day ]
    Reported as the number and percentage of participants that needed the use of Magill forceps during intubation


Secondary Outcome Measures :
  1. Time to Intubation [ Time Frame: 1 day ]
    Reported as the average time it took to intubate (seconds).

  2. Grade of Larynx View [ Time Frame: 1 day ]
    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).

  3. Presence of Nasal Bleeding [ Time Frame: 1 day ]
    Number of participants that experienced nasal bleeding was recorded.

  4. Incidence of Failed Nasal Intubation [ Time Frame: 1 day ]
    The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.



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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03032263


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Thomas W Templeton, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Publications of Results:
Other Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03032263    
Other Study ID Numbers: CMac-032016
First Posted: January 26, 2017    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No