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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Carassiti, Professor | Campus BioMedico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Campus BioMedico | Rome | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21965048 | Result | 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. |
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After written consent, thirty adult patients scheduled for elective surgery under general anaesthesia (age between 18 and 65 years, body-mass index between 18 and 30, classified as ASA-PS class 1 or 2), were included in this study. Subjects likely to be difficult to intubate, according to the SIAARTI Recommendations, were excluded.
Date of recruitment period: January-October 2011. Type of location: Dept. of Anaesthesia, University School of Medicine Campus Bio-Medico, Rome, Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Laryngoscope | Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers. |
| FG001 | 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 using film pressure transducers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Laryngoscope | Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers. |
| BG001 | Indirect Laryngoscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1. | Posted | Mean | Standard Deviation | Newton | Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia |
|
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Serious and/or other non-serious adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Direct Laryngoscope | Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Massimiliano Carassiti | Campus Bio-medico University | +39-06-225411952 | m.carassiti@unicampus.it |
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Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 using film pressure transducers. |
|
|
| 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. | We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1. | Posted | Mean | Standard Deviation | seconds | On average 20 seconds |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 using film pressure transducers. | 0 | 15 | 0 | 15 |
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