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

• Sponsor: Inonu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03908775
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation; Videolaryngoscopy; Children	Device: C-MAC videolaryngoscope; Device: Direct Laryngoscope	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation in Children: A Randomized, Controlled Clinical Trial
• Actual Study Start Date: Apr 15, 2019
• Actual Primary Completion Date: Sep 20, 2019
• Actual Study Completion Date: Apr 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to intubation [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 Outcome Measures

1. Heart Rate [From beginning of Anesthesia induction to 10th minutes of intubation]

   Heart Rate

2. Mean Arterial Pressure [From beginning of Anesthesia induction to 10th minutes of intubation]

   Mean Arterial Pressure

3. Adverse Events [During the first 1 hour postoperatively]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inonu University	Malatya		Turkey	44090

Sponsors and Collaborators

• Inonu University

Investigators

• Principal Investigator: Ulku Ozgul, Inonu University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ülkü Özgül, Associate professor, Inonu University
• ClinicalTrials.gov Identifier: NCT03908775
• Other Study ID Numbers: UlkuNT
• First Posted: Apr 9, 2019
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ülkü Özgül, Associate professor, Inonu University: Intubation; Children; Hemodynamics

Study Results

No Results Posted as of May 1, 2020