Adverse Anesthesia OutcomeNCT02856672
Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway
A study testing Supreme Laryngeal Mask Airway and Laryngeal Tube Suction Disposable in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial summary
The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Supreme Laryngeal Mask Airway and Laryngeal Tube Suction Disposable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ASA I and II with normal airways, for minor elective surgical
Who cannot join
- Age <18 yr, weight <50 kg, or > 100 kg , a known difficult airway, active gastro esophageal reflux disease
About this study
Official title: A Randomized Prospective Controlled Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway: The Influence of Head and Neck Position on Oropharyngeal Seal Pressure
The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.
Read the detailed description
Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.
To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Supreme Laryngeal Mask Airway, Laryngeal Tube Suction Disposable
- Keywords
- Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supreme Laryngeal Mask AirwayDevice
Supreme Laryngeal Mask Airway
Laryngeal Tube Suction DisposableDevice
Laryngeal Tube Suction Disposable
| Study group | Role | What they receive |
|---|---|---|
| Supreme Laryngeal Mask Airway | Active comparator | Supreme Laryngeal Mask Airway Receives: Device: Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable |
| Laryngeal Tube Suction Disposable | Active comparator | Laryngeal Tube Suction Disposable Receives: Device: Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome oropharyngeal seal pressures, in cm H2O
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O)
Measured: 5 min
Secondary outcomes (1)
Fiberoptic position
Scoring system of the fiberoptic view: ranged from grade 4 (full view of arytenoids and glottis), 3 (arytenoids and glottis partly visible), 2 (view of arytenoids, glottis or epiglottis), and 1 (no part of larynx identifiable).
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionOct 2012
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 Adverse Anesthesia OutcomeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Hospital Italiano de Buenos Aires
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
- Investigators
- Luis A Gaitini, M.D., Principal investigator, Bnai Zion Medical Center and Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856672
- Sponsor's protocol ID
- BnaiZionMC-16-LG-001
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Somri M, Vaida S, Garcia Fornari G, Mendoza GR, Charco-Mora P, Hawash N, Matter I, Swaid F, Gaitini L. A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure. BMC Anesthesiol. 2016 Oct 6;16(1):87. doi: 10.1186/s12871-016-0237-7.
PubMed 27716165
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Controlled Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway: The Influence of Head and Neck Position on Oropharyngeal Seal Pressure
- ClinicalTrials.gov ID
- NCT02856672
- Acronym / sponsor ID
- BnaiZionMC-16-LG-001
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Hospital Italiano de Buenos Aires
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Aug 2016 (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 investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.
Detailed description
Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.
To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme Laryngeal Mask Airway | Active comparator | Device: Supreme Laryngeal Mask Airway, Device: Laryngeal Tube Suction DisposableSupreme Laryngeal Mask Airway |
| Laryngeal Tube Suction Disposable | Active comparator | Device: Supreme Laryngeal Mask Airway, Device: Laryngeal Tube Suction DisposableLaryngeal Tube Suction Disposable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ASA I and II with normal airways, for minor elective surgical
Key exclusion criteria (1 listed)
- Age <18 yr, weight <50 kg, or > 100 kg , a known difficult airway, active gastro esophageal reflux disease
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 Laryngeal Mask AirwaySupreme Laryngeal Mask Airway | Device | Laryngeal Tube Suction Disposable, Supreme Laryngeal Mask Airway |
| Laryngeal Tube Suction DisposableLaryngeal Tube Suction Disposable | Device | Laryngeal Tube Suction Disposable, Supreme Laryngeal Mask Airway |
Primary outcome
Primary outcome oropharyngeal seal pressures, in cm H2O
Time frame: 5 min
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O)
1 secondary outcome
Fiberoptic position
Time frame: 5 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 27716165Somri M, Vaida S, Garcia Fornari G, Mendoza GR, Charco-Mora P, Hawash N, Matter I, Swaid F, Gaitini L. A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure. BMC Anesthesiol. 2016 Oct 6;16(1):87. doi: 10.1186/s12871-016-0237-7.
- Individual participant dataSharing planned: Yes
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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.
Luis A Gaitini, M.D. principal investigator
Bnai Zion Medical Center and Hospital Italiano de Buenos Aires
Questions about this trial
What is this clinical trial studying?
A study testing Supreme Laryngeal Mask Airway and Laryngeal Tube Suction Disposable in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome oropharyngeal seal pressures, in cm H2O (time frame: 5 min). 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 NCT02856672, 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 5 Aug 2016.