EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-12-31

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.

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Detailed Description

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Conditions

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Anesthesia Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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EcoAnesthesia Mask first

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.

Group Type ACTIVE_COMPARATOR

EcoAnaesthesia facemask first

Intervention Type DEVICE

The trial facemask will be used before the standard one.

Portex Adult (Standard) facemask second

Intervention Type DEVICE

The standard facemask will be applied after the trial device

Standard mask first

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.

Group Type ACTIVE_COMPARATOR

Portex Adult (Standard) facemask first

Intervention Type DEVICE

The standard facemask will be applied before the trial device.

EcoAnesthesia facemask second

Intervention Type DEVICE

The trial facemask will be used after the standard one.

Interventions

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EcoAnaesthesia facemask first

The trial facemask will be used before the standard one.

Intervention Type DEVICE

Portex Adult (Standard) facemask first

The standard facemask will be applied before the trial device.

Intervention Type DEVICE

Portex Adult (Standard) facemask second

The standard facemask will be applied after the trial device

Intervention Type DEVICE

EcoAnesthesia facemask second

The trial facemask will be used after the standard one.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No