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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

Tracking Information
First Submitted Date  ICMJE January 12, 2017
First Posted Date  ICMJE January 26, 2017
Results First Submitted Date  ICMJE June 14, 2018
Results First Posted Date  ICMJE July 11, 2018
Last Update Posted Date August 8, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date August 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Percentage of Nasal Intubations Requiring Use of Magill Forceps [ Time Frame: The primary outcome will be assessed directly following the nasal intubation for each patient ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • Time to Intubation [ Time Frame: 1 day ]
    Reported as the average time it took to intubate (seconds).
  • 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).
  • Presence of Nasal Bleeding [ Time Frame: 1 day ]
    Number of participants that experienced nasal bleeding was recorded.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Time to Intubation [ Time Frame: The secondary outcome will be assessed directly following the nasal intubation for each patient ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation
Official Title  ICMJE A Comparison of Direct Laryngoscopy and Video Laryngoscopy Using the C-Mac in Pediatric Nasal Intubations
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Nasal Intubation
Intervention  ICMJE
  • Device: Video Laryngoscopy for nasal intubation
    The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
  • Device: Direct Laryngoscopy
    These patients will be nasally intubated for their procedure via direct laryngoscopy
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Video Laryngoscopy for nasal intubation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
70
Actual Study Completion Date  ICMJE August 7, 2017
Actual Primary Completion Date August 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032263
Other Study ID Numbers  ICMJE CMac-032016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas W Templeton, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP