The Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscope for Nasotracheal Intubation in Children
Primary Purpose
Intubation; Difficult or Failed, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
HugeMed Videolaryngoscope
Sponsored by
About this trial
This is an interventional other trial for Intubation; Difficult or Failed
Eligibility Criteria
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.)
Sites / Locations
- Aydın Adnan Menderes University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Videolaryngoscope Group
Control Group
Arm Description
The group that we will use a videolaryngoscope for nasotracheal intubation.
The group that we will use a direct laryngoscope for nasotracheal intubation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05121597
First Posted
October 21, 2021
Last Updated
April 14, 2023
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05121597
Brief Title
The Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscope for Nasotracheal Intubation in Children
Official Title
Nasotracheal Intubation in Dental Treatments Under General Anesthesia in Children: Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult or Failed, Postoperative Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Single blinded
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videolaryngoscope Group
Arm Type
Experimental
Arm Description
The group that we will use a videolaryngoscope for nasotracheal intubation.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The group that we will use a direct laryngoscope for nasotracheal intubation.
Intervention Type
Device
Intervention Name(s)
HugeMed Videolaryngoscope
Other Intervention Name(s)
Direct laryngoscope
Intervention Description
Macintosh laryngoscope
Primary Outcome Measure Information:
Title
Intubation difficulty scale
Description
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.
Time Frame
At the time of intubation
Secondary Outcome Measure Information:
Title
Postoperative throat pain
Description
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).
Time Frame
Postoperative 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Facility Information:
Facility Name
Aydın Adnan Menderes University
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We wiil not share individual participant data (IPD).
Citations:
PubMed Identifier
26986776
Citation
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.
Results Reference
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The Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscope for Nasotracheal Intubation in Children
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