Intubation; Difficult or FailedNCT05121597
The Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscope for Nasotracheal Intubation in Children
A study testing HugeMed Videolaryngoscope in people with Intubation; Difficult or Failed and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Postoperative Pain
- What is being tested?
- HugeMed Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasotracheal Intubation in Dental Treatments Under General Anesthesia in Children: Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscopy
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.
Read the 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.
- Being tested
- HugeMed Videolaryngoscope
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HugeMed VideolaryngoscopeDevice
Also called Direct laryngoscope
Macintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope Group | Experimental | The group that we will use a videolaryngoscope for nasotracheal intubation. Receives: Device: HugeMed Videolaryngoscope |
| Control Group | Active comparator | The group that we will use a direct laryngoscope for nasotracheal intubation. Receives: Device: HugeMed Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of intubation
Secondary outcomes (1)
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).
Measured: Postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start31 Dec 2021
- Primary completion15 Feb 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Kocaturk, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121597
- Sponsor's protocol ID
- OKocaturk
- Status last verified
- Nov 2023
- First submitted
- 21 Oct 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We wiil not share individual participant data (IPD).
Publications
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.
PubMed 26986776Kocaturk 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.
PubMed 38829609
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation in Dental Treatments Under General Anesthesia in Children: Comparison of Direct Macintosh Laryngoscopy and HugeMed Video Laryngoscopy
- ClinicalTrials.gov ID
- NCT05121597
- Acronym / sponsor ID
- OKocaturk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope Group | Experimental | Device: HugeMed VideolaryngoscopeThe group that we will use a videolaryngoscope for nasotracheal intubation. |
| Control Group | Active comparator | Device: HugeMed VideolaryngoscopeThe group that we will use a direct laryngoscope for nasotracheal intubation. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HugeMed VideolaryngoscopeAlso: Direct laryngoscopeMacintosh laryngoscope | Device | Control Group, Videolaryngoscope Group |
Primary outcome
Intubation difficulty scale
Time frame: 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.
1 secondary outcome
Postoperative throat pain
Time frame: Postoperative 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 26986776Kim 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.
- Derived from this study: PubMed 38829609Kocaturk 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.
- Individual participant dataSharing planned: No. We wiil not share individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HugeMed Videolaryngoscope in people with Intubation; Difficult or Failed and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation difficulty scale (time frame: At the time of intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121597, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.