Inadequate or Impaired Breathing Pattern or VentilationSPLMANCT01814306
Supreme LMA and Proseal LMA in Prone Anesthetized Patient
A study testing Supreme LMA and Proseal LMA in people with Inadequate or Impaired Breathing Pattern or Ventilation, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
There is no significant difference about success rate of two devices. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Inadequate or Impaired Breathing Pattern or Ventilation
- What is being tested?
- Supreme LMA and Proseal LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2011to Jun 2013
- 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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society Anesthesiologists physical status I-III
- Patient undergo elective orthopedics surgery in prone position under general anaesthesia
Who cannot join
- Age <15year
- Non-fast
- Morbid obesity (BMI > 35kg/m2)
- Pregnancy
- Known or predicted difficult airway
- GERD
Show all 10Show fewer
- History of laryngeal problem (injury,subglottic stenosis)
- Local pharyngeal problem (abscess,tumor)
- Poor dentation
- Pulmonary disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position
There is no significant difference about success rate of two devices.
Read the detailed description
There is no significant difference about success rate of two device: efficacy and safety
- Being tested
- Supreme LMA, Proseal LMA
- Keywords
- LMA Supreme,LMA Proseal,airway management,prone position
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supreme LMADevice
Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion
Proseal LMADevice
Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion
| Study group | Role | What they receive |
|---|---|---|
| Supreme | Active comparator | Supreme LMA Receives: Device: Supreme LMA |
| Proseal | Active comparator | Proseal LMA Receives: Device: Proseal LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of insertion (quality of ventilation)
Measured: 1 year
Secondary outcomes (1)
Ease of insertion, Complication and Glottic seal pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startOct 2011
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequate or Impaired Breathing Pattern or VentilationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chatchai Prechawai, Prince of Songkla University
- Investigators
- Chatchai Prechawai, Study chair, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814306
- Sponsor's protocol ID
- SPLMA-100
- Other IDs
- SPLMA-100-CPrechawai
- Acronym
- SPLMA
- Status last verified
- Mar 2013
- First submitted
- 12 Feb 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position
- ClinicalTrials.gov ID
- NCT01814306
- Acronym / sponsor ID
- SPLMA / SPLMA-100
- Keywords
- LMA Supreme,LMA Proseal,airway management,prone position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Mar 2013 (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.
There is no significant difference about success rate of two devices.
Detailed description
There is no significant difference about success rate of two device: efficacy and safety
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme | Active comparator | Device: Supreme LMASupreme LMA |
| Proseal | Active comparator | Device: Proseal LMAProseal LMA |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society Anesthesiologists physical status I-III
- Patient undergo elective orthopedics surgery in prone position under general anaesthesia
Key exclusion criteria (10 listed)
- Age <15year
- Non-fast
- Morbid obesity (BMI > 35kg/m2)
- Pregnancy
- Known or predicted difficult airway
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 |
|---|---|---|
| Supreme LMAUse Supreme LMA to compare efficay with Proseal LMA in prone position insertion | Device | Supreme |
| Proseal LMAUse Proseal LMA to compare efficay with Supreme LMA in prone position insertion | Device | Proseal |
Primary outcome
Success rate of insertion (quality of ventilation)
Time frame: 1 year
1 secondary outcome
Ease of insertion, Complication and Glottic seal pressure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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.
Chatchai Prechawai study chair
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supreme LMA and Proseal LMA in people with Inadequate or Impaired Breathing Pattern or Ventilation, run by Prince of Songkla University at 1 site in Thailand.
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 10 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 19 Mar 2013. 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 Thailand. 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?
Results are not available in the source record.
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?
Success rate of insertion (quality of ventilation) (time frame: 1 year). 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 19 Mar 2013.