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

NCT01685320 | Completed Results DMC

• 1 other identifier: PressureCara
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Intubation; Laryngoscopy

Keywords

Force; Pressure; Intubation; laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation

  On average 20 seconds

Study Arms (2)

Direct laryngoscope

ACTIVE COMPARATOR

Includes cases in which the forces applied by Macintosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.

Procedure: Forces applied by laryngoscope

Indirect laryngoscope

ACTIVE COMPARATOR

Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.

Procedure: Forces applied by laryngoscope

Interventions

Forces applied by laryngoscope PROCEDURE

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

Direct laryngoscope; Indirect laryngoscope

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

University Hospital Campus BioMedico

Rome, 00128, Italy

Location

Related Publications (1)

• 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.

  PMID: 21965048 RESULT

Limitations and Caveats

1. Patients studied were classified with "normal airways", while difficult intubations were not considered. 2. We excluded patients with CL grade 2 or greater. 3. We employed only the Macintosh size 3 blade to avoid additional variables.

Results Point of Contact

• Title: Prof. Massimiliano Carassiti
• Organization: Campus Bio-medico University

m.carassiti@unicampus.it

+39-06-225411952

Study Officials

• Massimiliano Carassiti, Professor

  Campus BioMedico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 14, 2012
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 11, 2021
• Results First Posted: March 13, 2013

Record last verified: 2021-01

Locations

IT (1)