Tooth InjuriesNCT01599312
Forces on Teeth During Videolaryngoscopy
A study testing Forces exerted on teeth during intubation in people with Tooth Injuries and Intubation Complication, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare them with a classic Macintosh laryngoscope blade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Injuries, Intubation Complication
- What is being tested?
- Forces exerted on teeth during intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed patient consent
- ASA I -III
- Age > 18 years
- Elective surgery, other than head and/or throat surgery
- Pre-operative Mallampati I -III
- Fasted (≥6 hours)
Who cannot join
- No informed patient consent
- ASA ≥ IV
- Age < 18 year
- Emergency surgery, surgery of head and/of throat
- Locoregional anaesthesia
- Pre-operative Mallampati IV
Show all 10Show fewer
- Fasted < 6 hours
- Pre-operative expected difficult airway
- No teeth, bad dentition
- Dental crowns and/or fixed partial denture
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.
In this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare them with a classic Macintosh laryngoscope blade.
Read the detailed description
During endotracheal intubation the anesthesiologist uses a laryngoscope blade to distract the tongue to achieve the best view of the glottis opening, thereby avoiding using the maxillary incisors as a fulcrum to lever the soft tissues upwards. Using the maxillary incisors as a fulcrum may otherwise result in dental trauma. It is obvious that contact with teeth and - even worse - the incidence of accidental dental trauma, is directly related to the difficulty of the intubation.
Indirect videolaryngoscopy has proven advantageous over direct laryngoscopy using a classic Macintosh blade, for improved viewing of the glottis, with subsequent more successful intubations, and a shorter effective airway time both in patients with normal and difficult airways. Previously, it has been demonstrated that the forces exerted by the anesthesiologist on the patient's maxillary incisors are reduced when using a VLS, compared with a classic Macintosh laryngoscope. However, only one type of VLS (V-MAC®, Karl Storz, Tuttlingen, Germany) was used or only forces applied to upper teeth were being registered.
- Conditions
- Tooth Injuries, Intubation Complication
- Being tested
- Forces exerted on teeth during intubation
- Keywords
- Videolaryngoscopy, Forces, Teeth
- Medical subject headings
- Tooth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forces exerted on teeth during intubationDevice
Also called Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany), McGrath® (Aircraft Medical Ltd, Edinburgh, UK), C-MAC® (Karl Storz, Tuttlingen, Germany), GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA).
Anesthesia will be induced in the conventional matter. The classic Macintosh laryngoscope will be placed in the patient's mouth and a tube will be brought into position in front of the glottis. Hereafter, one of the three videolaryngoscopes will be placed in the patient's mouth and the endotracheal tube will be actually passed through the vocal cords. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.
| Study group | Role | What they receive |
|---|---|---|
| Classic Macintosh laryngoscope | Other | Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany) Receives: Device: Forces exerted on teeth during intubation |
| McGrath® | Other | McGrath® (Aircraft Medical Ltd, Edinburgh, UK) Receives: Device: Forces exerted on teeth during intubation |
| C-MAC® | Other | C-MAC® (Karl Storz, Tuttlingen, Germany) Receives: Device: Forces exerted on teeth during intubation |
| GlideScope® Cobalt | Other | GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA) Receives: Device: Forces exerted on teeth during intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the frequency with which forces are applied to the upper and lower teeth.
One of the three videolaryngoscopes will be placed in the patient's mouth. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.
Measured: At intubation of the patient
Secondary outcomes (1)
Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.
Measured: At intubation of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
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 Tooth InjuriesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbe Pieters, Catharina Ziekenhuis Eindhoven
- Investigators
- Andre A van Zundert, MD PhD FRCA, Study director, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599312
- Sponsor's protocol ID
- NL39915.060.12
- Other IDs
- M12-1217
- Status last verified
- Feb 2015
- First submitted
- 14 May 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee RA, van Zundert AA, Maassen RL, Willems RJ, Beeke LP, Schaaper JN, van Dobbelsteen J, Wieringa PA. Forces applied to the maxillary incisors during video-assisted intubation. Anesth Analg. 2009 Jan;108(1):187-91. doi: 10.1213/ane.0b013e31818d1904.
PubMed 19095848Lee RA, van Zundert AA, Maassen RL, Wieringa PA. Forces applied to the maxillary incisors by video laryngoscopes and the Macintosh laryngoscope. Acta Anaesthesiol Scand. 2012 Feb;56(2):224-9. doi: 10.1111/j.1399-6576.2011.02541.x. Epub 2011 Oct 14.
PubMed 22091734
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.
- ClinicalTrials.gov ID
- NCT01599312
- Acronym / sponsor ID
- NL39915.060.12
- Conditions
- Tooth Injuries, Intubation Complication
- Keywords
- Videolaryngoscopy, Forces, Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 May 2012 (estimated)
- 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.
In this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare them with a classic Macintosh laryngoscope blade.
Detailed description
During endotracheal intubation the anesthesiologist uses a laryngoscope blade to distract the tongue to achieve the best view of the glottis opening, thereby avoiding using the maxillary incisors as a fulcrum to lever the soft tissues upwards. Using the maxillary incisors as a fulcrum may otherwise result in dental trauma. It is obvious that contact with teeth and - even worse - the incidence of accidental dental trauma, is directly related to the difficulty of the intubation.
Indirect videolaryngoscopy has proven advantageous over direct laryngoscopy using a classic Macintosh blade, for improved viewing of the glottis, with subsequent more successful intubations, and a shorter effective airway time both in patients with normal and difficult airways. Previously, it has been demonstrated that the forces exerted by the anesthesiologist on the patient's maxillary incisors are reduced when using a VLS, compared with a classic Macintosh laryngoscope. However, only one type of VLS (V-MAC®, Karl Storz, Tuttlingen, Germany) was used or only forces applied to upper teeth were being registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Classic Macintosh laryngoscope | Other | Device: Forces exerted on teeth during intubationClassic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany) |
| McGrath® | Other | Device: Forces exerted on teeth during intubationMcGrath® (Aircraft Medical Ltd, Edinburgh, UK) |
| C-MAC® | Other | Device: Forces exerted on teeth during intubationC-MAC® (Karl Storz, Tuttlingen, Germany) |
| GlideScope® Cobalt | Other | Device: Forces exerted on teeth during intubationGlideScope® Cobalt (Verathon Medical, Bothell, WA, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed patient consent
- ASA I -III
- Age > 18 years
- Elective surgery, other than head and/or throat surgery
- Pre-operative Mallampati I -III
Key exclusion criteria (10 listed)
- No informed patient consent
- ASA ≥ IV
- Age < 18 year
- Emergency surgery, surgery of head and/of throat
- Locoregional anaesthesia
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 |
|---|---|---|
| Forces exerted on teeth during intubationAlso: Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany), McGrath® (Aircraft Medical Ltd, Edinburgh, UK), C-MAC® (Karl Storz, Tuttlingen, Germany), GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA).Anesthesia will be induced in the conventional matter. The classic Macintosh laryngoscope will be placed in the patient's mouth and a tube will be brought into position in front of the glottis. Hereafter, one of the three videolaryngoscopes will be placed in the patient's mouth and the endotracheal tube will be actually passed through the vocal cords. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors. | Device | C-MAC®, Classic Macintosh laryngoscope, GlideScope® Cobalt, McGrath® |
Primary outcome
Measuring the frequency with which forces are applied to the upper and lower teeth.
Time frame: At intubation of the patient
One of the three videolaryngoscopes will be placed in the patient's mouth. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.
1 secondary outcome
Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.
Time frame: At intubation of the patient
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 10 Feb 2015.
- Background: PubMed 19095848Lee RA, van Zundert AA, Maassen RL, Willems RJ, Beeke LP, Schaaper JN, van Dobbelsteen J, Wieringa PA. Forces applied to the maxillary incisors during video-assisted intubation. Anesth Analg. 2009 Jan;108(1):187-91. doi: 10.1213/ane.0b013e31818d1904.
- Background: PubMed 22091734Lee RA, van Zundert AA, Maassen RL, Wieringa PA. Forces applied to the maxillary incisors by video laryngoscopes and the Macintosh laryngoscope. Acta Anaesthesiol Scand. 2012 Feb;56(2):224-9. doi: 10.1111/j.1399-6576.2011.02541.x. Epub 2011 Oct 14.
Related trials for Tooth Injuries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
RecruitingObservational study
The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)
Traumatic Brain Injury
Active, not recruiting
Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery
Wound Heal, Surgical Wound
Recruiting
The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children
Idiopathic Toe Walking, Cerebral Palsy
Not yet recruitingObservational study
Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI Model
Postoperative Infections, Mandibular Nerve Injuries
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.
Andre A van Zundert, MD PhD FRCA study director
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forces exerted on teeth during intubation in people with Tooth Injuries and Intubation Complication, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 6 inclusion and 10 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 10 Feb 2015. 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 Netherlands. 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?
Measuring the frequency with which forces are applied to the upper and lower teeth. (time frame: At intubation of the patient). 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 NCT01599312, 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 10 Feb 2015; AzTrials last refreshed its copy on 27 Oct 2026.