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Clinical Trials/NCT03908775
NCT03908775
Completed
Not Applicable

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

Inonu University1 site in 1 country102 target enrollmentApril 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
Inonu University
Enrollment
102
Locations
1
Primary Endpoint
Time to intubation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
April 25, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ülkü Özgül

Associate professor

Inonu University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to intubation

Time Frame: From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Time to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected

Secondary Outcomes

  • Heart Rate(From beginning of Anesthesia induction to 10th minutes of intubation)
  • Mean Arterial Pressure(From beginning of Anesthesia induction to 10th minutes of intubation)
  • Adverse Events(During the first 1 hour postoperatively)

Study Sites (1)

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