NCT05121597

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Intubation; Difficult or Failed
• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	HugeMed Videolaryngoscope	Macintosh laryngoscope

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-02-15
• Completion: 2022-12-30
• First posted: 2021-11-16
• Last updated: 2023-11-27

Locations

1 site across 1 country: Turkey (Türkiye)