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

Nasotracheal Intubation in Dental Treatments Under General Anesthesia in Children: Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscopy

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Intubation; Difficult or Failed
• Intervention / Treatment: Device: HugeMed Videolaryngoscope

Detailed Description

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 included and divided into 2 groups randomly. 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 time from the moment the laryngoscope touches the patient until the endotracheal tube is inserted and the end-tidal carbon dioxide is detected will be recorded as intubation time, and the Cormack and Lehane glottic scale score will be recorded when the best glottic view is obtained. 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.

Desaturation (SpO2 < 90%) will be assessed during intubation, Hemodynamic data will be recorded at four points in time: at baseline (before induction, T0); 1 min after induction (T1); in intubation (T2); and 5 minutes after intubation (T3).

Intubation time, Intubation Difficulty Scale (IDS), C&L grade, number of intubation attempts, External Throat Manuplation, Intubation related trauma-bleeding, Intubation-related pain scores will be recorded in the case report form. In addition, age, gender, weight, ASA status of patients, blade and tube size, operation time, number of caries-filled extracted teeth (dmft) values will also be recorded. The patient whose operation is completed will be taken to the recovery room. Post-operative discomfort will be recorded in the case report form.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydin, Turkey, 09100
    • Aydın Adnan Menderes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Videolaryngoscope Group; The group that we will use a videolaryngoscope for nasotracheal intubation.	Device: HugeMed Videolaryngoscope; Macintosh laryngoscope; Other Names: Direct laryngoscope
Active Comparator: Control Group; The group that we will use a direct laryngoscope for nasotracheal intubation.	Device: HugeMed Videolaryngoscope; Macintosh laryngoscope; Other Names: Direct laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative throat pain	Postoperative pain due to intubation was evaluated by visual analogue scale (VAS). Pain visual analog scale (VAS) score (0-10, 0 indicating no pain, 10 indicating the intolerable pain).	Postoperative 1 hour

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: OKocaturk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We wiil not share individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No