Oropharyngeal Space in Videolaryngoscopy
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Purpose
In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.
| Condition | Intervention |
|---|---|
|
Abrasion of Soft Palate Intubation Complication |
Device: C-MAC ® videolaryngoscope Device: Coopdech® videolaryngoscope Device: McGrath® Series 5 videolaryngoscope Device: Glidescope® Cobalt videolaryngoscope Device: King Vision® videolaryngoscope Device: Venner® videolaryngoscope Device: McGrath® MAC |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade |
- Palatopharyngeal distance [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Two laryngoscopes (one classic direct laryngoscope and one indirect videolaryngoscope) will subsequently be inserted into the patient's mouth at random order. With each laryngoscope the horizontal distance between the laryngoscope blade and mid-palatopharyngeal fold will be measured using an mm ruler.
- Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Investigating how this space differs from the space that remains on the right side of the blade of the classic Macintosh laryngoscope and the palatopharyngeal wall in the same cohort of patients.
- Difference in palatopharyngeal distance between videolaryngoscopes [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.
- Cormack-Lehane score [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]Registering difficulty of intubation (Cormack-Lehane score)
- Successful intubation [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Registering the number of successful intubations.
- Use of rigid stylet [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Use of rigid stylet during intubation
- Number of attempts [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Number of intubation attempts
- Time until picking up endotracheal tube [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]Time until picking up endotracheal tube
- Epiglottic down-folding [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]Occurrence of epiglottic down-folding
- Complications [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]Any complication that occurs during intubation will be registered.
| Estimated Enrollment: | 489 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Coopdech® videolaryngoscope |
Device: Coopdech® videolaryngoscope
Coopdech® videolaryngoscope
Other Name: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
|
| C-MAC® videolaryngoscope |
Device: C-MAC ® videolaryngoscope
C-MAC ® videolaryngoscope
Other Name: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
|
| McGrath® Series 5 videolaryngoscope |
Device: McGrath® Series 5 videolaryngoscope
McGrath® Series 5 videolaryngoscope
Other Name: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
|
| Glidescope® Cobalt videolaryngoscope |
Device: Glidescope® Cobalt videolaryngoscope
Glidescope® Cobalt videolaryngoscope
Other Name: Glidescope® Cobalt (Verathon, Bothell, USA)
|
| King Vision® videolaryngoscope |
Device: King Vision® videolaryngoscope
King Vision® videolaryngoscope
Other Name: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
|
| Venner® videolaryngoscope |
Device: Venner® videolaryngoscope
Venner® videolaryngoscope
Other Name: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
|
| McGrath MAC® videolaryngoscope |
Device: McGrath® MAC
McGrath® MAC (Aircraft Medical, Edinburgh, UK)
Other Name: McGrath® MAC (Aircraft Medical, Edinburgh, UK)
|
Detailed Description:
Intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the Macintosh laryngoscope. There are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. Different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. The space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. Positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed patient consent
- ASA I - III
- Age > 18 years
- Elective surgery, other than head and/or neck surgery
- Pre-operative Mallampati I - III
- BMI < 35 kg/m2
- Fasted (≥6 hours)
Exclusion Criteria:
- No informed patient consent
- ASA ≥ IV
- Age < 18 year
- Emergency surgery, surgery of head and/of neck
- Locoregional anaesthesia
- Pre-operative Mallampati IV
- BMI > 35 kg/m2
- Fasted < 6 hours
- Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia)
- Bad, fragile dentition
- Dental crowns and/or fixed partial denture
Contacts and Locations| Contact: Barbe M Pieters, MD | bmapieters@gmail.com | |
| Contact: Andre A van Zundert, MD PhD FRCA | zundert@iae.nl |
| Netherlands | |
| Catharina Ziekenhuis Eindhoven | Recruiting |
| Eindhoven, Noord-Brabant, Netherlands, 5602 ZA | |
| Contact: Barbe M Pieters, MD bmapieters@gmail.com | |
| Study Director: | Andre A van Zundert, MD PhD FRCA | Catharina Ziekenhuis Eindhoven |
More Information
Publications:
| Responsible Party: | Barbe Pieters, Principal Investigator, Catharina Ziekenhuis Eindhoven |
| ClinicalTrials.gov Identifier: | NCT01609101 History of Changes |
| Other Study ID Numbers: | M12-1210, M12-1210 |
| Study First Received: | May 24, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Catharina Ziekenhuis Eindhoven:
|
Videolaryngoscopy Palatopharyngeal distance Trauma |
Additional relevant MeSH terms:
|
Cobalt Trace Elements Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013