Tracheal Intubation Clinical Trial
Official title:
Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
NCT number | NCT01685320 |
Other study ID # | PressureCara |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | December 2011 |
Verified date | January 2021 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital Campus BioMedico | Rome |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
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
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 |
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