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
|Condition or disease||Intervention/treatment||Phase|
|Nasal Intubation||Device: Video Laryngoscopy for nasal intubation Device: Direct Laryngoscopy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|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|
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.
- 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
- 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.
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
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Thomas W Templeton, MD||Wake Forest University Health Sciences|