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

NCT03908775 | Completed

• 1 other identifier: UlkuNT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Videolaryngoscopy; Children

Keywords

Intubation; Children; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

Group VL

ACTIVE COMPARATOR

C-MAC Videolaryngoscope Patients intubated with C-MAC Videolaryngoscope

Device: C-MAC videolaryngoscope

Group DL

ACTIVE COMPARATOR

Direct Laryngoscope Patients intubated with Direct laryngoscope

Device: Direct Laryngoscope

Interventions

C-MAC videolaryngoscope DEVICE

An intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

Group VL

Direct Laryngoscope DEVICE

An intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope.

Group DL

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years
• American Society of Anesthesiology score I-II,
• undergoing dental procedure
• required nasotracheal intubation

You may not qualify if:

• Patients for risk of aspiration
• Upper airway abnormalities
• Known difficult airways

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (1)

• Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.

  PMID: 21244568 RESULT

Study Officials

• Ulku Ozgul

  Inonu University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 9, 2019
• Study Start: April 15, 2019
• Primary Completion: September 20, 2019
• Study Completion: April 25, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)