Morbid ObesityPhase 3NCT01724970
Laryngeal Masks for Bariatric Surgery
A Phase 3 study testing ProSeal and Supreme LMA in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
Trial summary
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- ProSeal and Supreme LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Jul 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-III
- candidates to bariatric surgery
Who cannot join
- uncontrolled psychiatric symptomatology
- known or presumed pregnancy
- history of surgery on the airway or esophagus
- gastroesophageal reflux
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Padua
Padua, PD, 35121
Michele Carron, MD, +39 049 8211111 ext. 3090, michele.carron@unipd.it
Ulderico Freo, MD, +39 049 8211111 ext. 3094, ulderico.freo@unipd.it
About this study
Official title: A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.
Read the detailed description
The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.
- Conditions
- Morbid Obesity
- Being tested
- ProSeal, Supreme LMA
- Keywords
- anesthesia, postanesthetic recovery, ventilation, bariatric surgery
- Medical subject headings
- Obesity, Morbid, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSealDevice
Patients will be ventilated with PLMA
Supreme LMADevice
Patients will be ventilated with SLMA
| Study group | Role | What they receive |
|---|---|---|
| PLMA | Experimental | ProSeal Receives: Device: ProSeal |
| SLMA | Experimental | Supreme LMA Receives: Device: Supreme LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
oropharyngeal leak pressure
Measured: intraoperatively, up to 3 hours
Secondary outcomes (10)
total anesthetic and analgesic drug dosages
Measured: intraoperatively and postoperatively, up to 24 hours from end of surgery
pulse oximetry saturation
Measured: intraoperatively and postoperatively, up to 24 hours from end of surgery
time to post-anesthetic discharge scoring system (PADSS) > 8
Measured: in PACU up 72 hours
EKG monitoring
Measured: postoperatively up to 72 hours
satisfaction of the surgeon (ad hoc questionnaire)
Measured: day 1
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
Measured: day 1
gastric distension
Measured: intraoperatively up to 3 hours
levels of pain and nausea (Visual Analogue Scale)
Measured: postoperatively up to 24 hours
metilen's blue
Measured: before end of surgery up to 3 hours
total dosage of analgesic and antihemetic drugs
Measured: intra and postoperatively up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Responsible party
- Sponsor
- Investigators
- Michele Carron, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724970
- Sponsor's protocol ID
- 2276P
- Status last verified
- Nov 2012
- First submitted
- 14 Sep 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT01724970
- Acronym / sponsor ID
- 2276P
- Conditions
- Morbid Obesity
- Keywords
- anesthesia, postanesthetic recovery, ventilation, bariatric surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 12 Nov 2012 (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.
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.
Detailed description
The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLMA | Experimental | Device: ProSealProSeal |
| SLMA | Experimental | Device: Supreme LMASupreme LMA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class I-III
- candidates to bariatric surgery
Key exclusion criteria (4 listed)
- uncontrolled psychiatric symptomatology
- known or presumed pregnancy
- history of surgery on the airway or esophagus
- gastroesophageal 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 |
|---|---|---|
| ProSealPatients will be ventilated with PLMA | Device | PLMA |
| Supreme LMAPatients will be ventilated with SLMA | Device | SLMA |
Primary outcome
oropharyngeal leak pressure
Time frame: intraoperatively, up to 3 hours
10 secondary outcomes
total anesthetic and analgesic drug dosages
Time frame: intraoperatively and postoperatively, up to 24 hours from end of surgery
pulse oximetry saturation
Time frame: intraoperatively and postoperatively, up to 24 hours from end of surgery
time to post-anesthetic discharge scoring system (PADSS) > 8
Time frame: in PACU up 72 hours
EKG monitoring
Time frame: postoperatively up to 72 hours
satisfaction of the surgeon (ad hoc questionnaire)
Time frame: day 1
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
Time frame: day 1
gastric distension
Time frame: intraoperatively up to 3 hours
levels of pain and nausea (Visual Analogue Scale)
Time frame: postoperatively up to 24 hours
metilen's blue
Time frame: before end of surgery up to 3 hours
total dosage of analgesic and antihemetic drugs
Time frame: intra and postoperatively up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Related trials for Morbid Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
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.
Michele Carron, MD principal investigator
University of Padova
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 ProSeal and Supreme LMA in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
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 2 inclusion and 4 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 12 Nov 2012. 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 Italy. 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 Michele Carron, MD (+39 049 821 3090, michele.carron@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oropharyngeal leak pressure (time frame: intraoperatively, up to 3 hours). 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 12 Nov 2012.