Anesthesia InductionNCT01103947
EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction
A study testing EcoAnaesthesia facemask first, Portex Adult (Standard) facemask first and Portex Adult (Standard) facemask second in people with Anesthesia Induction, run by University of Louisville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia Induction
- What is being tested?
- EcoAnaesthesia facemask first, Portex Adult (Standard) facemask first and Portex Adult (Standard) facemask second
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class 1-2
- Undergoing elective surgery
- Aged between 18 and 75 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia
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.
- Conditions
- Anesthesia Induction
- Being tested
- EcoAnaesthesia facemask first, Portex Adult (Standard) facemask first, Portex Adult (Standard) facemask second, EcoAnesthesia facemask second
- Keywords
- Anesthesia induction, Facemask, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcoAnaesthesia facemask firstDevice
The trial facemask will be used before the standard one.
Portex Adult (Standard) facemask firstDevice
The standard facemask will be applied before the trial device.
Portex Adult (Standard) facemask secondDevice
The standard facemask will be applied after the trial device
EcoAnesthesia facemask secondDevice
The trial facemask will be used after the standard one.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EcoAnaesthesia facemask first; Device: 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. Receives: Device: Portex Adult (Standard) facemask first; Device: EcoAnesthesia facemask second |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal oxygen concentration
End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.
Measured: three minutes
Secondary outcomes (1)
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.
Measured: End of 3 minutes with each mask
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2014
Why it stopped: Not able to finalize funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Detlef Obal, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103947
- Sponsor's protocol ID
- UoL IRB 09.0588
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2010
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19293691
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT01103947
- Acronym / sponsor ID
- UoL IRB 09.0588
- Conditions
- Anesthesia Induction
- Keywords
- Anesthesia induction, Facemask, surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to finalize funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EcoAnesthesia Mask first | Active comparator | Device: EcoAnaesthesia facemask first, Device: Portex Adult (Standard) facemask secondBoth 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 | Active comparator | Device: Portex Adult (Standard) facemask first, Device: EcoAnesthesia facemask secondBoth 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status class 1-2
- Undergoing elective surgery
- Aged between 18 and 75 years
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EcoAnaesthesia facemask firstThe trial facemask will be used before the standard one. | Device | EcoAnesthesia Mask first |
| Portex Adult (Standard) facemask firstThe standard facemask will be applied before the trial device. | Device | Standard mask first |
| Portex Adult (Standard) facemask secondThe standard facemask will be applied after the trial device | Device | EcoAnesthesia Mask first |
| EcoAnesthesia facemask secondThe trial facemask will be used after the standard one. | Device | Standard mask first |
Primary outcome
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.
1 secondary outcome
Maximum airway pressure
Time frame: End of 3 minutes with each mask
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Background: PubMed 19293691Kheterpal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Detlef Obal, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EcoAnaesthesia facemask first, Portex Adult (Standard) facemask first and Portex Adult (Standard) facemask second in people with Anesthesia Induction, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-tidal oxygen concentration (time frame: three minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01103947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.