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

NCT ID: NCT05121597

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-30

Brief Summary

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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

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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

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Intubation; Difficult or Failed Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Single blinded

Study Groups

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Videolaryngoscope Group

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

Group Type EXPERIMENTAL

HugeMed Videolaryngoscope

Intervention Type DEVICE

Macintosh laryngoscope

Control Group

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

Group Type ACTIVE_COMPARATOR

HugeMed Videolaryngoscope

Intervention Type DEVICE

Macintosh laryngoscope

Interventions

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HugeMed Videolaryngoscope

Macintosh laryngoscope

Intervention Type DEVICE

Other Intervention Names

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Direct laryngoscope

Eligibility Criteria

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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.)
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Kocaturk

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aydın Adnan Menderes University

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26986776 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38829609 (View on PubMed)

Other Identifiers

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OKocaturk

Identifier Type: -

Identifier Source: org_study_id