EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01103947
First received: April 13, 2010
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Anesthesia Induction
Device: EcoAnaesthesia facemask first
Device: Portex Adult (Standard) facemask first
Device: Portex Adult (Standard) facemask second
Device: EcoAnesthesia facemask second
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • End-tidal oxygen concentration [ Time Frame: three minues ] [ Designated as safety issue: Yes ]
    End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.


Secondary Outcome Measures:
  • Maximum airway pressure [ Time Frame: End of 3 minutes with each mask ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EcoAnesthesia Mask 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.
Device: EcoAnaesthesia facemask first
The trial facemask will be used before the standard one.
Device: Portex Adult (Standard) facemask second
The standard facemask will be applied after the trial device
Active Comparator: Standard mask 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.
Device: Portex Adult (Standard) facemask first
The standard facemask will be applied before the trial device.
Device: EcoAnesthesia facemask second
The trial facemask will be used after the standard one.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103947

Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Detlef Obal, MD University of Louisville
  More Information

Publications:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01103947     History of Changes
Other Study ID Numbers: UoL IRB 09.0588
Study First Received: April 13, 2010
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Anesthesia induction
Facemask
surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014