Adverse Anesthesia OutcomeNCT02866890
The New Laryngeal Tube Suction-Disposable for Childrens
A study testing Laryngeal Tube Suction in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial summary
The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Oct 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
Inclusion Criteria:Pediatric patients, ASA I and II, normal airway, for minor elective surgery
Exclusion Criteria: Weigth <10Kg or > 30 Kg, known difficult airway, active esophagial reflux
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study
The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
Read the detailed description
The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of < 155 cm (> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients < 5 Kg.
As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version.
The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Laryngeal Tube Suction
- Keywords
- Laryngeal Tube Suction, seal pressure, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Tube SuctionDevice
Also called VBM Medical, Sulz, Germany
Laryngeal Tube Suction Measurement of leak pressure
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Tube Suction size 1 | Experimental | Measurement of leak pressure Receives: Device: Laryngeal Tube Suction |
| Laryngeal Tube Suction size 2 | Experimental | Measurement of leak pressure Receives: Device: Laryngeal Tube Suction |
| Laryngeal Tube Suction size 2.5 | Experimental | Measurement of leak pressure Receives: Device: Laryngeal Tube Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seal pressure in cm H2O
We will measure the seal leak pressure at 60 cm H2O intracuff pressure and the minimal pressure of the cuff to performed effective volume controlled ventilation
Measured: one minute
Secondary outcomes (1)
Time of insertion in seconds
Was measured as the time after the anesthesiologist removed the facemask until the square-wave capnograph tracing was observed after insertion of the LTS-D. Two attempts at insertion were permitted.
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2017 (estimated)
- Study completionOct 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 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
- Investigators
- Luis A Gaitini, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866890
- Sponsor's protocol ID
- BnaiZionMC-16-LG-003
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 15 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 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study
- ClinicalTrials.gov ID
- NCT02866890
- Acronym / sponsor ID
- BnaiZionMC-16-LG-003
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Laryngeal Tube Suction, seal pressure, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 15 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 Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
Detailed description
The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of < 155 cm (> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients < 5 Kg.
As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version.
The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Tube Suction size 1 | Experimental | Device: Laryngeal Tube SuctionMeasurement of leak pressure |
| Laryngeal Tube Suction size 2 | Experimental | Device: Laryngeal Tube SuctionMeasurement of leak pressure |
| Laryngeal Tube Suction size 2.5 | Experimental | Device: Laryngeal Tube SuctionMeasurement of leak pressure |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 SuctionAlso: VBM Medical, Sulz, GermanyLaryngeal Tube Suction Measurement of leak pressure | Device | Laryngeal Tube Suction size 1, Laryngeal Tube Suction size 2, Laryngeal Tube Suction size 2.5 |
Primary outcome
Seal pressure in cm H2O
Time frame: one minute
We will measure the seal leak pressure at 60 cm H2O intracuff pressure and the minimal pressure of the cuff to performed effective volume controlled ventilation
1 secondary outcome
Time of insertion in seconds
Time frame: one minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Tube Suction 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?
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 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis A Gaitini, M.D. (# 972 4 8359361, luis.gaitini@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seal pressure in cm H2O (time frame: one minute). 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 15 Aug 2016.