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Clinical Trials/NCT01103947
NCT01103947WithdrawnNot Applicable

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

University of Louisville2 sites in 1 countryStarted: April 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
End-tidal oxygen concentration
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

End-tidal oxygen concentration

Time Frame: three minutes

End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.

Secondary Outcomes

  • Maximum airway pressure(End of 3 minutes with each mask)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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