Clinical trial NCT01685320: Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Official title: Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Laryngoscopy
Keywords: Force
Pressure
Intubation
laryngoscopy
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Forces applied on soft upper tissues by different laryngoscope blades during direct laryngoscopy and intubation are considered to be major stimuli to cause serious damages to the patients. The aim of this study is to compare the force and pressure applied to soft tissue in order to achieve the same glottis view comparing direct laryngoscopy and videolaryngoscopy in vivo.

Detailed description: Forces applied on soft upper tissues by different laryngoscope blades during direct laryngoscopy and intubation are considered to be major stimuli to cause serious damages to the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.

In order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes alignment, thereby reducing the detrimental effects above mentioned.

The aim of this study is to measure the minimal force exertion to achieve not only glottis view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in patients with normal airway conditions. Furthermore, The investigators measured the following parameters: pressure distribution upon the blade; time required to visualize the glottis; time required to complete oro-tracheal intubation.

Eligibility criteria: Inclusion Criteria:

* Patients classified as American Society of Anesthesiologists physical status (ASA-PS) class 1 or 2
* Patients whose intubation was associated with a Cormack-Lehane grade 1

Exclusion Criteria:

* younger than 18 yrs
* older than 65 yrs
* body-mass index (BMI) between 18 and 30
* predicted difficult intubation according to SIAARTI (Italian Society Anaesthesia, Analgesia, Resuscitation and Intensive Care)

Primary outcomes:
measure: Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.
timeFrame: Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
Secondary outcomes:
measure: Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation
timeFrame: On average 20 seconds
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital Campus BioMedico
Study officials:
affiliation: Campus BioMedico
name: Massimiliano Carassiti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agro FE. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal and difficult airways: a manikin study. Br J Anaesth. 2012 Jan;108(1):146-51. doi: 10.1093/bja/aer304. Epub 2011 Sep 28.