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Completed

NCT Number: NCT01685320

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

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.

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Key information

Conditions

Tracheal Intubation Laryngoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Campus BioMedico

Rome, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

    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 outcomes

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

    Time frame: On average 20 seconds

    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.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2012
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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