EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

Not Applicable

Withdrawn

• Conditions: Anesthesia Induction
• Interventions: Device: Portex Adult (Standard) facemask first; Device: EcoAnaesthesia facemask first; Device: Portex Adult (Standard) facemask second; Device: EcoAnesthesia facemask second

• Registration Number: NCT01103947
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EcoAnesthesia Mask first	Portex Adult (Standard) facemask second	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.
Standard mask first	Portex Adult (Standard) facemask 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.
Standard mask first	EcoAnesthesia facemask second	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.
EcoAnesthesia Mask first	EcoAnaesthesia facemask 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States