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

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05121597
Collaborator
(none)
44
2
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HugeMed Videolaryngoscope
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Single blinded
Primary Purpose:
Other
Official Title:
Nasotracheal Intubation in Dental Treatments Under General Anesthesia in Children: Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscopy
Anticipated Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Feb 15, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Intubation difficulty scale [At the time of intubation]

      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.

    Secondary Outcome Measures

    1. Postoperative throat pain [Postoperative 1 hour]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aydin Adnan Menderes University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ozlem Kocaturk, Associate Professor, Aydin Adnan Menderes University
    ClinicalTrials.gov Identifier:
    NCT05121597
    Other Study ID Numbers:
    • OKocaturk
    First Posted:
    Nov 16, 2021
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021