IntubationNCT03908775
A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation
A study testing C-MAC videolaryngoscope and Direct Laryngoscope in people with Intubation and Videolaryngoscopy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Nasotracheal intubation is indicated in patients undergoing oral, maxillofacial, or dental procedures. During nasal intubation with the traditional Macintosh laryngoscope, use of Magill's forceps or external laryngeal manipulation is usually required to facilitate intubation. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Intubation, Videolaryngoscopy, Children
- What is being tested?
- C-MAC videolaryngoscope and Direct Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 25 Apr 2020
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-12 years
- American Society of Anesthesiology score I-II,
- undergoing dental procedure
- required nasotracheal intubation
Who cannot join
- Patients for risk of aspiration
- Upper airway abnormalities
- Known difficult airways
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation in Children: A Randomized, Controlled Clinical Trial
Nasotracheal intubation is indicated in patients undergoing oral, maxillofacial, or dental procedures. During nasal intubation with the traditional Macintosh laryngoscope, use of Magill's forceps or external laryngeal manipulation is usually required to facilitate intubation. The prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries.
The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes.
In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.
Read the detailed description
Tracheal intubation using direct laryngoscopy is successful in the majority of patients, even when a line-of-sight view of the glottis is not possible. Although poor glottic visualization is encountered between 1% and 9% of attempts, success can generally be achieved with additional force, external laryngeal manipulation, or the use of gum elastic bougies and stylets. However, poor glottic exposure is more likely to require prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries. In recent years, videolaryngoscopy has begun to play an important role in the management of patients with an unanticipated difficult or failed laryngoscopic intubation.
The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes.
In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.
- Conditions
- Intubation, Videolaryngoscopy, Children
- Being tested
- C-MAC videolaryngoscope, Direct Laryngoscope
- Keywords
- Intubation, Children, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC videolaryngoscopeDevice
An intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
Direct LaryngoscopeDevice
An intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Group VL | Active comparator | C-MAC Videolaryngoscope Patients intubated with C-MAC Videolaryngoscope Receives: Device: C-MAC videolaryngoscope |
| Group DL | Active comparator | Direct Laryngoscope Patients intubated with Direct laryngoscope Receives: Device: Direct Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
Time to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected
Measured: From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Secondary outcomes (3)
Heart Rate
Heart Rate
Measured: From beginning of Anesthesia induction to 10th minutes of intubation
Mean Arterial Pressure
Mean Arterial Pressure
Measured: From beginning of Anesthesia induction to 10th minutes of intubation
Adverse Events
Bleeding in the mouth and nose, the Magill Forceps use, burst of intubation tube cuff, external laryngeal pressure, presence of head position change, laryngospasm, hypoxia.
Measured: During the first 1 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Apr 2019
- Primary completion20 Sep 2019
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Özgül, Inonu University
- Investigators
- Ulku Ozgul, Principal investigator, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908775
- Sponsor's protocol ID
- UlkuNT
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.
PubMed 21244568
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of C-MAC Videolaryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation in Children: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03908775
- Acronym / sponsor ID
- UlkuNT
- Conditions
- Intubation, Videolaryngoscopy, Children
- Keywords
- Intubation, Children, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 9 Apr 2019 (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.
Nasotracheal intubation is indicated in patients undergoing oral, maxillofacial, or dental procedures. During nasal intubation with the traditional Macintosh laryngoscope, use of Magill's forceps or external laryngeal manipulation is usually required to facilitate intubation. The prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries.
The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes.
In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.
Detailed description
Tracheal intubation using direct laryngoscopy is successful in the majority of patients, even when a line-of-sight view of the glottis is not possible. Although poor glottic visualization is encountered between 1% and 9% of attempts, success can generally be achieved with additional force, external laryngeal manipulation, or the use of gum elastic bougies and stylets. However, poor glottic exposure is more likely to require prolonged or multiple intubation attempts and, subsequently, may be associated with complications such as oxygen desaturation or airway and dental injuries. In recent years, videolaryngoscopy has begun to play an important role in the management of patients with an unanticipated difficult or failed laryngoscopic intubation.
The C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) is a videolaryngoscope using a modified Macintosh blade, which may be a useful alternative both for routine and difficult airway management and for educational purposes.
In this prospective, randomized, controlled trial, the purpose is to compare C-MAC and DL in terms of intubation times, hemodynamic response and adverse events associated with nasotracheal intubation in children undergoing dental procedures.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group VL | Active comparator | Device: C-MAC videolaryngoscopeC-MAC Videolaryngoscope Patients intubated with C-MAC Videolaryngoscope |
| Group DL | Active comparator | Device: Direct LaryngoscopeDirect Laryngoscope Patients intubated with Direct laryngoscope |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-12 years
- American Society of Anesthesiology score I-II,
- undergoing dental procedure
- required nasotracheal intubation
Key exclusion criteria (3 listed)
- Patients for risk of aspiration
- Upper airway abnormalities
- Known difficult airways
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 |
|---|---|---|
| C-MAC videolaryngoscopeAn intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope. | Device | Group VL |
| Direct LaryngoscopeAn intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope. | Device | Group DL |
Primary outcome
Time to intubation
Time frame: From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Time to intubation was defined as the time the nasotracheal tube was inserted into nares the until endtidal CO2 was detected
3 secondary outcomes
Heart Rate
Time frame: From beginning of Anesthesia induction to 10th minutes of intubation
Mean Arterial Pressure
Time frame: From beginning of Anesthesia induction to 10th minutes of intubation
Adverse Events
Time frame: During the first 1 hour postoperatively
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 1 May 2020.
- Results publication: PubMed 21244568Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.
- Individual participant dataSharing planned: No
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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.
Ulku Ozgul principal investigator
Inonu University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC videolaryngoscope and Direct Laryngoscope in people with Intubation and Videolaryngoscopy, run by Inonu 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 4 inclusion and 3 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 1 May 2020. 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?
Time to intubation (time frame: From beginning of inserting nasotracheal tube into nares to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes). 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 NCT03908775, which also lists 1 linked publication.
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 1 May 2020.