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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massimiliano Carassiti, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01685320
First received: September 7, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Tracheal Intubation.
Laryngoscopy.
Complications of Anesthetic Procedures.
Procedure: Forces applied by laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation. [ Time Frame: Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation [ Time Frame: On average 20 seconds ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Direct laryngoscope
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
Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
Active Comparator: Indirect laryngoscope
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
Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685320

Locations
Italy
University Hospital Campus BioMedico
Rome, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Principal Investigator: Massimiliano Carassiti, Professor Campus BioMedico
  More Information

Publications:
Responsible Party: Massimiliano Carassiti, Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01685320     History of Changes
Other Study ID Numbers: PressureCara
Study First Received: September 7, 2012
Results First Received: February 8, 2013
Last Updated: March 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Campus Bio-Medico University:
Force
Pressure
Intubation
laryngoscopy

ClinicalTrials.gov processed this record on September 14, 2014