Intubation Complication Clinical Trial
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Ziekenhuis Eindhoven | Eindhoven | Noord-Brabant |
Lead Sponsor | Collaborator |
---|---|
Catharina Ziekenhuis Eindhoven |
Netherlands,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At intubation of the patient | Yes |
Secondary | Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes. | At intubation of the patient | Yes |
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