EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

Anesthesia Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01103947
• Other study ID #: UoL IRB 09.0588
• Status: Withdrawn
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 6, 2017
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Induction

Intervention

Device:
• EcoAnaesthesia facemask first
The trial facemask will be used before the standard one.
• Portex Adult (Standard) facemask first
The standard facemask will be applied before the trial device.
• Portex Adult (Standard) facemask second
The standard facemask will be applied after the trial device
• EcoAnesthesia facemask second
The trial facemask will be used after the standard one.

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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