EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

University of Louisville (UOFL)

Status: Withdrawn

Conditions: Anesthesia Induction

Treatments: Device: EcoAnaesthesia facemask first; Device: Portex Adult (Standard) facemask first; Device: Portex Adult (Standard) facemask second; Device: EcoAnesthesia facemask second

Study type: Interventional

Funder types: Other

Identifiers

NCT01103947

UoL IRB 09.0588

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

EcoAnesthesia Mask first

Active Comparator group

Description:

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.

Treatment:

Device: EcoAnaesthesia facemask first

Device: Portex Adult (Standard) facemask second

Standard mask first

Active Comparator group

Description:

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.

Treatment:

Device: EcoAnesthesia facemask second

Device: Portex Adult (Standard) facemask first