Seal PressurePhase 3NCT01340638
Seal Pressure With Classical Laryngeal Mask and Cookgas Mask in Adult Patients
A Phase 3 study testing cookgas mask and LMA mask in people with Seal Pressure, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seal Pressure
- What is being tested?
- cookgas mask and LMA mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Patient ASA I, II and III
- Complete fast
- Ambulatory Surgery
- Time less than two hours surgically
- Supine Surgery
- Acceptance of informed consent
Who cannot join
- No acceptance of informed consent
- Pregnancy or breastfeeding
- Hemostatic alterations
- Abdominal surgery
- History of gastrointestinal reflux
- BMI over 35
Show all 9Show fewer
- Mouth opening less than 1.5 cm
- Airway abnormalities
- Surgery in respiratory tract
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Ips Universitaria
Medellín, Antioquia
IVAN D ARENAS, ANESTHETIST
About this study
Official title: EFFECTIVENESS OF SEAL PRESSURE IN AIRWAY OF THE CLASSIC LARYNGEAL MASK AND THE COOKGAS LARYNGEAL MASK IN ADULT PATIENTS UNDERGOING SURGERY IN AMBULATORY SETTINGS
The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.
- Conditions
- Seal Pressure
- Being tested
- cookgas mask, LMA mask
- Keywords
- Seal pressure, Cookgas, AirQ, LMA, supraglottic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cookgas maskDevice
This group will be assigned to use cookgas mask
LMA maskDevice
LMA mask
| Study group | Role | What they receive |
|---|---|---|
| Cookgas | Active comparator | This group will be assigned to use cookgas mask Receives: Device: cookgas mask |
| LMA mask | Active comparator | This group will be assigned to use LMA mask Receives: Device: LMA mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seal pressures
The primary objective is to determine the effectiveness of the seal pressure between the mask COOKGAS ™ and LMAc in patients undergoing outpatient surgeries in ambulatory-based IPS, University of Antioquia (institution services health clinic) located in the city of Medellin.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seal PressureStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo de via aerea dificil universidad de antioquia
- Investigators
- IVAN D ARENAS, ANESTHETIST, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340638
- Sponsor's protocol ID
- UAntioquia SEAL- 001
- Status last verified
- Apr 2011
- First submitted
- 19 Apr 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF SEAL PRESSURE IN AIRWAY OF THE CLASSIC LARYNGEAL MASK AND THE COOKGAS LARYNGEAL MASK IN ADULT PATIENTS UNDERGOING SURGERY IN AMBULATORY SETTINGS
- ClinicalTrials.gov ID
- NCT01340638
- Acronym / sponsor ID
- UAntioquia SEAL- 001
- Conditions
- Seal Pressure
- Keywords
- Seal pressure, Cookgas, AirQ, LMA, supraglottic device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Grupo de via aerea dificil universidad de antioquia
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Apr 2011 (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.
The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cookgas | Active comparator | Device: cookgas maskThis group will be assigned to use cookgas mask |
| LMA mask | Active comparator | Device: LMA maskThis group will be assigned to use LMA mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years
- Patient ASA I, II and III
- Complete fast
- Ambulatory Surgery
- Time less than two hours surgically
Key exclusion criteria (9 listed)
- No acceptance of informed consent
- Pregnancy or breastfeeding
- Hemostatic alterations
- Abdominal surgery
- History of gastrointestinal reflux
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 |
|---|---|---|
| cookgas maskThis group will be assigned to use cookgas mask | Device | Cookgas |
| LMA maskLMA mask | Device | LMA mask |
Primary outcome
Seal pressures
Time frame: six months
The primary objective is to determine the effectiveness of the seal pressure between the mask COOKGAS ™ and LMAc in patients undergoing outpatient surgeries in ambulatory-based IPS, University of Antioquia (institution services health clinic) located in the city of Medellin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
Related trials for Seal Pressure
Recruiting
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
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.
IVAN D ARENAS, ANESTHETIST principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cookgas mask and LMA mask in people with Seal Pressure, run by Universidad de Antioquia at 1 site in Colombia.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Apr 2011. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NORA M MENDOZA, MD (057 4 2506600, MARCEMS2@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seal pressures (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2011.