The Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscope for Nasotracheal Intubation in Children

NCT05121597 | Completed

• 1 other identifier: OKocaturk
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Forty-four patients aged 4-10 years who applied to Aydın Adnan Menderes University Faculty of Dentistry for dental treatment under general anesthesia will be selected and divided into 2 groups by simple randomization. The group in which a direct laryngoscope was used for intubation, which is a part of the routine general anesthesia procedure, Group DL; The group in which the video laryngoscope is used will be called Group VL. Routine general anesthesia procedure and dental treatments will not differ between groups. The necessity of external laryngeal manipulation, intubation difficulty scale (IDS) will be evaluated and the difficulty level will be determined as easy, medium and difficult. All intubations will be confirmed by auscultation as part of the routine procedure.

Conditions

Intubation; Difficult or Failed; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Intubation difficulty scale

  Difficulty level of intubation will be determined as easy, medium and difficult. The 3 classifications were as follows: if the IDS was 0 points, then it was considered an easy endotracheal intubation. If the score was 1-5 points, it was a slightly difficult intubation. More than 5 points was considered moderate-to-difficult intubation.

  At the time of intubation

Secondary Outcomes (1)

• Postoperative throat pain

  Postoperative 1 hour

Study Arms (2)

Videolaryngoscope Group

EXPERIMENTAL

The group that we will use a videolaryngoscope for nasotracheal intubation.

Device: HugeMed Videolaryngoscope

Control Group

ACTIVE COMPARATOR

The group that we will use a direct laryngoscope for nasotracheal intubation.

Device: HugeMed Videolaryngoscope

Interventions

HugeMed Videolaryngoscope DEVICE

Macintosh laryngoscope

Also known as: Direct laryngoscope

Control Group; Videolaryngoscope Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-10 years who cannot undergo dental treatment in a routine clinical setting (having a Frankl 1 and 2 behavior score) due to lack of cooperation,
• ASA (American Society of Anesthesiologist) Score 1 (no systemic disease),
• Cases with Mallampati Score I-II.

You may not qualify if:

• Suspect or history of difficult intubation,
• BMI (body mass index) greater than 35,
• Fast-series induction required,
• Nasal intubation is contraindicated,
• Cases in which general anesthesia is contraindicated (Drug allergies, advanced systemic disease, muscle diseases, etc.)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (2)

• Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.

  PMID: 26986776 BACKGROUND

• Kocaturk O, Keles S. Comparison of the HugeMed video laryngoscope with the Macintosh direct laryngoscope for nasotracheal tracheal intubation in children undergoing dental treatment: a randomized controlled clinical study. Expert Rev Med Devices. 2024 Jun 3:1-8. doi: 10.1080/17434440.2024.2363289. Online ahead of print.

  PMID: 38829609 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 16, 2021
• Study Start: December 31, 2021
• Primary Completion: February 15, 2022
• Study Completion: December 30, 2022
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)