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Oropharyngeal Space in Videolaryngoscopy

Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01609101
Enrollment
489
Registered
2012-05-31
Start date
2012-05-31
Completion date
2014-04-30
Last updated
2014-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abrasion of Soft Palate, Intubation Complication

Keywords

Videolaryngoscopy, Palatopharyngeal distance, Trauma

Brief summary

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.

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.

Interventions

DEVICEC-MAC ® videolaryngoscope

C-MAC ® videolaryngoscope

DEVICECoopdech® videolaryngoscope

Coopdech® videolaryngoscope

DEVICEMcGrath® Series 5 videolaryngoscope

McGrath® Series 5 videolaryngoscope

DEVICEGlidescope® Cobalt videolaryngoscope

Glidescope® Cobalt videolaryngoscope

DEVICEKing Vision® videolaryngoscope

King Vision® videolaryngoscope

DEVICEVenner® videolaryngoscope

Venner® videolaryngoscope

McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Palatopharyngeal distanceParticipants will be followed during induction of anesthesia, an expected average of 10 minTwo 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.

Secondary

MeasureTime frameDescription
Difference in palatopharyngeal distance between videolaryngoscopesParticipants will be followed during induction of anesthesia, an expected average of 10 minComparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.
Cormack-Lehane scoreParticipants will be followed during induction of anesthesia, an expected average of 10 minRegistering difficulty of intubation (Cormack-Lehane score)
Successful intubationParticipants will be followed during induction of anesthesia, an expected average of 10 minRegistering the number of successful intubations.
Use of rigid styletParticipants will be followed during induction of anesthesia, an expected average of 10 minUse of rigid stylet during intubation
Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscopeParticipants will be followed during induction of anesthesia, an expected average of 10 minInvestigating 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.
Time until picking up endotracheal tubeParticipants will be followed during induction of anesthesia, an expected average of 10 minTime until picking up endotracheal tube
Epiglottic down-foldingParticipants will be followed during induction of anesthesia, an expected average of 10 minOccurrence of epiglottic down-folding
ComplicationsParticipants will be followed during induction of anesthesia, an expected average of 10 minAny complication that occurs during intubation will be registered.
Number of attemptsParticipants will be followed during induction of anesthesia, an expected average of 10 minNumber of intubation attempts

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026