Adverse Anesthesia OutcomeNCT02859922
Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation
A study testing Laryngeal Tube Suction Disposable and Supreme Laryngeal Mask Airway in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in their structural design. 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?
- Laryngeal Tube Suction Disposable and Supreme Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Nov 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, American Society of Anesthesiologists ( ASA) physical status I and II, with normal airways for minor elective surgery.
Who cannot join
- Age <18 years,
- Weight <50 kg,
- Cervical spine disease limiting neck a known difficult airway, and
- Patients with active gastroesophageal reflux.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation: A Randomized Prospective Study
The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in their structural design.
Read the detailed description
The Supreme Laryngeal Mask Airway (SLMA), (Intavent Orthofix, Maidenhead, UK), and Laryngeal Tube Suction -Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), are second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The SLMA has been compared to the Proseal Laryngeal Mask Airway (PLMA) during mechanical and spontaneous ventilation the LTS II (multiple use version of the LTS-D) with the PLMA.
Recently, the LTS-D and SLMA have been compared when used during pressure controlled mechanical ventilation.
To date, there is no published data comparing the SLMA to the LTS-D during spontaneous ventilation. The investigators hypothesized that the SLMA and LTS-D perform similarly during spontaneous ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the SLMA and the LTS-D with respect to 1) Oxygen saturation and End Tidal carbone dioxide during spontaneous ventilation, 2) time to achieve an effective airway, 3) ease of insertion, 4) need for interventions to achieve an effective airway, 5) cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, 6) ventilatory variables during spontaneous ventilation, 7) fiberoptic score, 8) adverse perioperative events.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Laryngeal Tube Suction Disposable, Supreme Laryngeal Mask Airway
- Keywords
- Laryngeal Tube Supreme Spontaneous Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Tube Suction DisposableDevice
Laryngeal Tube Suction Disposable
Supreme Laryngeal Mask AirwayDevice
Supreme Laryngeal Mask Airway
| Study group | Role | What they receive |
|---|---|---|
| Supreme Laryngeal Mask Airway | Active comparator | Supreme Laryngeal Mask Airway Receives: Device: Supreme Laryngeal Mask Airway |
| Laryngeal Tube Suction Disposable | Active comparator | Laryngeal Tube Suction Disposable Receives: Device: Laryngeal Tube Suction Disposable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation in percent
The data were recorded by the Anesthesia Delivery Unit (Datex-Ohmeda, Helsinki, Finland). monitor from starting the establishment of spontaneous ventilation until the device was removed
Measured: 30 min
Secondary outcomes (1)
Time to achieve an effective airway in sec
The time was measured in seconds after the anesthesiologist removed the facemask and insert the device and the square-wave capnograph tracing was observed.Two attempts at insertion were permitted. If unsuccessful the patient's airway was managed with a conventional endotracheal tube.
Measured: 15 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
- Investigators
- Luis A Gaitini, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859922
- Sponsor's protocol ID
- BnaiZionMC-16-LG-002
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02859922
- Acronym / sponsor ID
- BnaiZionMC-16-LG-002
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Laryngeal Tube Supreme Spontaneous Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 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 study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in their structural design.
Detailed description
The Supreme Laryngeal Mask Airway (SLMA), (Intavent Orthofix, Maidenhead, UK), and Laryngeal Tube Suction -Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), are second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The SLMA has been compared to the Proseal Laryngeal Mask Airway (PLMA) during mechanical and spontaneous ventilation the LTS II (multiple use version of the LTS-D) with the PLMA.
Recently, the LTS-D and SLMA have been compared when used during pressure controlled mechanical ventilation.
To date, there is no published data comparing the SLMA to the LTS-D during spontaneous ventilation. The investigators hypothesized that the SLMA and LTS-D perform similarly during spontaneous ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the SLMA and the LTS-D with respect to 1) Oxygen saturation and End Tidal carbone dioxide during spontaneous ventilation, 2) time to achieve an effective airway, 3) ease of insertion, 4) need for interventions to achieve an effective airway, 5) cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, 6) ventilatory variables during spontaneous ventilation, 7) fiberoptic score, 8) adverse perioperative events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme Laryngeal Mask Airway | Active comparator | Device: Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway |
| Laryngeal Tube Suction Disposable | Active comparator | 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, American Society of Anesthesiologists ( ASA) physical status I and II, with normal airways for minor elective surgery.
Key exclusion criteria (4 listed)
- Age <18 years,
- Weight <50 kg,
- Cervical spine disease limiting neck a known difficult airway, and
- Patients with active 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 |
|---|---|---|
| Laryngeal Tube Suction DisposableLaryngeal Tube Suction Disposable | Device | Laryngeal Tube Suction Disposable |
| Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway | Device | Supreme Laryngeal Mask Airway |
Primary outcome
Oxygen saturation in percent
Time frame: 30 min
The data were recorded by the Anesthesia Delivery Unit (Datex-Ohmeda, Helsinki, Finland). monitor from starting the establishment of spontaneous ventilation until the device was removed
1 secondary outcome
Time to achieve an effective airway in sec
Time frame: 15 sec
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 17 Aug 2016.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Tube Suction Disposable and Supreme Laryngeal Mask Airway in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 17 Aug 2016. 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 Israel. 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 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?
Oxygen saturation in percent (time frame: 30 min). 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 17 Aug 2016.