EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103947

Enrollment

Registered

2010-04-15

Start date

2010-04-30

Completion date

2014-12-31

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Induction

Keywords

Anesthesia induction, Facemask, surgery

Brief summary

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.

Interventions

DEVICEEcoAnaesthesia facemask first

The trial facemask will be used before the standard one.

DEVICEPortex Adult (Standard) facemask first

The standard facemask will be applied before the trial device.

DEVICEPortex Adult (Standard) facemask second

The standard facemask will be applied after the trial device

DEVICEEcoAnesthesia facemask second

The trial facemask will be used after the standard one.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Maximum airway pressure	End of 3 minutes with each mask	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026