Adverse Anesthesia OutcomeNCT02977559
A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
A study testing Laryngeal Tube Suction Disposable and Laryngeal Mask Airway AuraGain in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial summary
The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Laryngeal Tube Suction Disposable and Laryngeal Mask Airway AuraGain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Sep 2017
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.
Who cannot join
- Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.
About this study
Official title: A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.
The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.
Read the detailed description
The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.
The two devices have now pediatric sizes.
To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:
- time to achieve an effective airway,
- ease of insertion,
- need for interventions to achieve an effective airway,
- cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,
- ventilatory variables during mechanical ventilation,
- fiberoptic score,
- gastric tube insertion and
- adverse perioperative events.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Laryngeal Tube Suction Disposable, Laryngeal Mask Airway AuraGain
- Keywords
- Laryngeal Tube Suction Ambu AuraGain Leak Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Tube Suction DisposableDevice
Device for ventilation
Laryngeal Mask Airway AuraGainDevice
Ventilation device
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Tube Suction Disposable | Experimental | Laryngeal Tube Suction Disposable for ventilation Receives: Device: Laryngeal Tube Suction Disposable |
| Laryngeal Mask Airway AuraGain | Experimental | Laryngeal Mask Airway AuraGain for oxygenation and ventilation Receives: Device: Laryngeal Mask Airway AuraGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leak pressure measure in cm H2O
Measured: 60 seconds
Secondary outcomes (1)
Time to insertion a device in seconds
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startMar 2017
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977559
- Sponsor's protocol ID
- BnaiZionMC-16-LG-012
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 1 Dec 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 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02977559
- Acronym / sponsor ID
- BnaiZionMC-16-LG-012
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Laryngeal Tube Suction Ambu AuraGain Leak Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Nov 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 Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.
The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.
Detailed description
The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.
The two devices have now pediatric sizes.
To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:
- time to achieve an effective airway,
- ease of insertion,
- need for interventions to achieve an effective airway,
- cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,
- ventilatory variables during mechanical ventilation,
- fiberoptic score,
- gastric tube insertion and
- adverse perioperative events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Tube Suction Disposable | Experimental | Device: Laryngeal Tube Suction DisposableLaryngeal Tube Suction Disposable for ventilation |
| Laryngeal Mask Airway AuraGain | Experimental | Device: Laryngeal Mask Airway AuraGainLaryngeal Mask Airway AuraGain for oxygenation and ventilation |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.
Key exclusion criteria (1 listed)
- Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.
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 DisposableDevice for ventilation | Device | Laryngeal Tube Suction Disposable |
| Laryngeal Mask Airway AuraGainVentilation device | Device | Laryngeal Mask Airway AuraGain |
Primary outcome
Leak pressure measure in cm H2O
Time frame: 60 seconds
1 secondary outcome
Time to insertion a device in seconds
Time frame: 60 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Tube Suction Disposable and Laryngeal Mask Airway AuraGain 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: status not confirmed, as of the sponsor's last update on 1 Dec 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?
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?
Leak pressure measure in cm H2O (time frame: 60 seconds). 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 1 Dec 2016.