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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121597
• Other study ID #: OKocaturk
• Status: Completed
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2023
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 30, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Intubation; Difficult or Failed
• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• HugeMed Videolaryngoscope
Macintosh laryngoscope

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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