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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03908775
Enrollment
102
Registered
2019-04-09
Start date
2019-04-15
Completion date
2020-04-25
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Videolaryngoscopy, Children

Keywords

Intubation, Children, Hemodynamics

Brief summary

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

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.

Interventions

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.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to intubationFrom beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutesTime to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected

Secondary

MeasureTime frameDescription
Heart RateFrom beginning of Anesthesia induction to 10th minutes of intubationHeart Rate
Mean Arterial PressureFrom beginning of Anesthesia induction to 10th minutes of intubationMean Arterial Pressure
Adverse EventsDuring the first 1 hour postoperativelyBleeding in the mouth and nose, the Magill Forceps use, burst of intubation tube cuff, external laryngeal pressure, presence of head position change, laryngospasm, hypoxia.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026