A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation

Study Overview
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Brief Summary
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Nasotracheal intubation is indicated in patients undergoing oral, maxillofacial, or dental procedures. During nasal intubation with the traditional Macintosh laryngoscope, use of Magill's forceps or external laryngeal manipulation is usually required to facilitate intubation. The prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries. The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes. In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.

Detailed Description
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Tracheal intubation using direct laryngoscopy is successful in the majority of patients, even when a line-of-sight view of the glottis is not possible. Although poor glottic visualization is encountered between 1% and 9% of attempts, success can generally be achieved with additional force, external laryngeal manipulation, or the use of gum elastic bougies and stylets. However, poor glottic exposure is more likely to require prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries. In recent years, videolaryngoscopy has begun to play an important role in the management of patients with an unanticipated difficult or failed laryngoscopic intubation. The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes. In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.

Official Title
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A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation in Children: A Randomized, Controlled Clinical Trial

Conditions
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Intubation, Videolaryngoscopy, Children

Intervention / Treatment
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* Device: C-MAC videolaryngoscope
* Device: Direct Laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-12 years American Society of Anesthesiology score I-II, undergoing dental procedure required nasotracheal intubation Exclusion Criteria: Patients for risk of aspiration Upper airway abnormalities Known difficult airways

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group VL<br>C-MAC Videolaryngoscope Patients intubated with C-MAC Videolaryngoscope | Device: C-MAC videolaryngoscope<br>* An intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.<br>|
| Active Comparator: Group DL<br>Direct Laryngoscope Patients intubated with Direct laryngoscope | Device: Direct Laryngoscope<br>* An intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation | Time to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected | From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate | From beginning of Anesthesia induction to 10th minutes of intubation | 
| Mean Arterial Pressure | Mean Arterial Pressure | From beginning of Anesthesia induction to 10th minutes of intubation | 
| Adverse Events | Bleeding in the mouth and nose, the Magill Forceps use, burst of intubation tube cuff, external laryngeal pressure, presence of head position change, laryngospasm, hypoxia. | During the first 1 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Children, Hemodynamics