Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study

Tracheal Intubation Clinical Trial

Official title:

Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685320
• Other study ID #: PressureCara
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2021
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laryngoscopy
• Tracheal Intubation

Intervention

Procedure:
• Forces applied by laryngoscope
Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.

Locations

Country	Name	City	State
Italy	University Hospital Campus BioMedico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agrò 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/ae — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.	The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.	Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
Secondary	Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation	Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.	On average 20 seconds