Measuring the space on the right side of the videolaryngoscope blade and the palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening (Mallampati I, II and III). We also want to investigate how this space differs from the…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary parameter is: Measuring the space on the right side of the
videolaryngoscope blade and the palatopharyngeal wall in a cohort of ASA I-III
patients with a normal mouth opening (Mallampati I, II and III).
Secondary outcome
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.
Comparing the difference in remaining space between the different
videolaryngoscopes.
Registering difficulty of intubation (Cormack-Lehane score), successful
intubation, use of rigid stylet, number of attempts, time until picking up
endotracheal tube, epiglottic downfolding and any complication during
intubation.
Background summary
Intubation using indirect videolaryngoscopy has many advantages over classic
direct laryngoscopy using the Macintosh laryngoscope. The laryngoscope blade
differs between the different brands of videolaryngoscopes. The size and angle
of these blade differ significantly, which may have an impact in 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
a rigid styletted endotracheal tube was used.
Study objective
Measuring the space on the right side of the videolaryngoscope blade and the
palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth
opening (Mallampati I, II and III). We also want to investigate 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.
Study design
Randomised crossover trial
Study burden and risks
The burden for patients will be minimal, since the patient will be anesthetized
during the time of the study.
Probably the risk of dental trauma is slightly increased, since two
laryngoscopes will be placed (instead of 1). However, videolaryngscopy has been
proven to result in reduced forces on teeth, and more importantly, patients
with bad or fragile dentition will be excluded. Also, other risk factors for
dental trauma will be excluded as much as possible (intubation will only be
performed by an experienced anesthesiologist, emergency surgery is excluded as
are patients with external features predicting a difficult airway).
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
ASA I, II and III patients, aged > 18 years, who will undergo an elective surgical procedure under general anaesthesia.
Exclusion criteria
ASA IV patients undergoing emergence surgery with pre-operatively expected difficult airway, bad or fragile dentition, dental crowns and/or fixed partial denture
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38570.060.12 |