An interventional study of C-MAC videolaryngoscope and Direct Laryngoscope in Intubation, Videolaryngoscopy and Children, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-05-01.
Sponsored by Inonu University · Not applicable, Interventional, and Screening
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.
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.
Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
C-MAC Videolaryngoscope Patients intubated with C-MAC Videolaryngoscope
Device: C-MAC videolaryngoscope
Direct Laryngoscope Patients intubated with Direct laryngoscope
Device: Direct Laryngoscope
An intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
An intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope.
Time to intubation
Time to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected
Time frame: From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Heart Rate
Heart Rate
Time frame: From beginning of Anesthesia induction to 10th minutes of intubation
Mean Arterial Pressure
Mean Arterial Pressure
Time frame: 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.
Time frame: During the first 1 hour postoperatively
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Inonu University