Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Rome, Italien, 00128
- University Hospital Campus BioMedico
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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.
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Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
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Aktiv komparator: 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.
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Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.
Tidsramme: Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
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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.
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Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation
Tidsramme: On average 20 seconds
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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.
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On average 20 seconds
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Massimiliano Carassiti, Professor, Campus Biomedico
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PressureCara
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