NCT01103947

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

April 13, 2010

Last Update Submit

April 6, 2017

Conditions

Anesthesia Induction

Keywords

Anesthesia inductionFacemasksurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maximum airway pressure

    End of 3 minutes with each mask

Study Arms (2)

EcoAnesthesia Mask first

ACTIVE COMPARATOR

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 firstDevice: Portex Adult (Standard) facemask second

Standard mask first

ACTIVE COMPARATOR

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 firstDevice: EcoAnesthesia facemask second

Interventions

EcoAnaesthesia facemask firstDEVICE

The trial facemask will be used before the standard one.

EcoAnesthesia Mask first
Portex Adult (Standard) facemask firstDEVICE

The standard facemask will be applied before the trial device.

Standard mask first
Portex Adult (Standard) facemask secondDEVICE

The standard facemask will be applied after the trial device

EcoAnesthesia Mask first
EcoAnesthesia facemask secondDEVICE

The trial facemask will be used after the standard one.

Standard mask first

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status class 1-2
  • Undergoing elective surgery
  • Aged between 18 and 75 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related 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.

    PMID: 19293691BACKGROUND

Study Officials

  • Detlef Obal, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)