EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

Study Overview
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Brief Summary
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This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.

Official Title
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A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia

Conditions
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Anesthesia Induction

Intervention / Treatment
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* Device: EcoAnaesthesia facemask first
* Device: Portex Adult (Standard) facemask first
* Device: Portex Adult (Standard) facemask second
* Device: EcoAnesthesia facemask second


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status class 1-2 Undergoing elective surgery Aged between 18 and 75 years Exclusion Criteria: Severe acute or chronic lung disease requiring oxygen-therapy; Hiatus hernia with gastro-esophageal reflux or other esophageal or gastric abnormalities that require a rapid sequence induction; Food intake within the last 6 hours or clear fluid intake within 2 hours prior to surgery; Ischemic or congenital heart disease; Pregnancy (confirmed by a pregnancy test); Patient is scheduled for regional anesthesia and denies conductance of general anesthesia during the surgical procedure; Known difficult intubation in the past. Difficult Mask Ventilation. Patients having any two of the criteria listed below will be Categorized as Difficult Mask Ventilation (DMV) (5,13,14) and will be excluded from enrollment. All others will be classified as Normal. Age > 55 BMI > 26 kg/m2 Lack of teeth Presence of beard History of snoring Limited mandibular protrusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EcoAnesthesia Mask first<br>Both the standard adult facemask (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. This group will receive the EcoAnesthesia Mask first. | Device: EcoAnaesthesia facemask first<br>* The trial facemask will be used before the standard one.<br>Device: Portex Adult (Standard) facemask second<br>* The standard facemask will be applied after the trial device<br>|
| Active Comparator: Standard mask first<br>Both the standard adult facemask (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. Patients in this arm will receive the standard mask first. | Device: Portex Adult (Standard) facemask first<br>* The standard facemask will be applied before the trial device.<br>Device: EcoAnesthesia facemask second<br>* The trial facemask will be used after the standard one.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal oxygen concentration | End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use. | three minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum airway pressure | Maximum airway pressure, which will be necessary to reach a tidal volume of at least 6 ml/kg every minute during the 3 minutes of mask ventilation with each device. | End of 3 minutes with each mask | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia induction, Facemask, surgery