Forces on Teeth During Videolaryngoscopy

NCT ID: NCT01599312

Last Updated: 2015-02-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Injuries Intubation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Classic Macintosh laryngoscope

Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany)

Group Type OTHER

Forces exerted on teeth during intubation

Intervention Type DEVICE

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.

McGrath®

McGrath® (Aircraft Medical Ltd, Edinburgh, UK)

Group Type OTHER

Forces exerted on teeth during intubation

Intervention Type DEVICE

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.

C-MAC®

C-MAC® (Karl Storz, Tuttlingen, Germany)

Group Type OTHER

Forces exerted on teeth during intubation

Intervention Type DEVICE

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.

GlideScope® Cobalt

GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)

Group Type OTHER

Forces exerted on teeth during intubation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Forces exerted on teeth during intubation

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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). Flexiforce® sensors (A201-25, Tekscan, MA, USA)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* No informed patient consent
* ASA ≥ IV
* Age \< 18 year
* Emergency surgery, surgery of head and/of throat
* Locoregional anaesthesia
* Pre-operative Mallampati IV
* Fasted \< 6 hours
* Pre-operative expected difficult airway
* No teeth, bad dentition
* Dental crowns and/or fixed partial denture
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbe Pieters

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andre A van Zundert, MD PhD FRCA

Role: STUDY_DIRECTOR

Catharina Ziekenhuis Eindhoven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19095848 (View on PubMed)

Lee 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.

Reference Type BACKGROUND
PMID: 22091734 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M12-1217

Identifier Type: OTHER

Identifier Source: secondary_id

NL39915.060.12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.