Airway ManagementiLTS-D2NCT03942809
Clinical Evaluation of the Revised iLTS-D2
A study testing Effectiveness in people with Airway Management, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Effectiveness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2019to 15 Apr 2020
- 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
- elective surgery patients under general Anesthesia
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability
A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.
Read the detailed description
The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.
- Conditions
- Airway Management
- Being tested
- Effectiveness
- Keywords
- Airway Morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EffectivenessDevice
Effectiveness and Practicability in anesthetized patient under controlled conditions
| Study group | Role | What they receive |
|---|---|---|
| Effectiveness | Experimental | Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation Receives: Device: Effectiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion time LT
Insertion of the laryngeal tube
Measured: in 30 seconds
Secondary outcomes (5)
Insertion time ET
Insertion of the endotracheal tube
Measured: in 60 seconds
Rate of successful Intubation attempts
successful insertion and tracheal intubation
Measured: through study completion, an average of 120 seconds
hemodynamics MAP
changes in MAP (mmHg) during cuff insufflation of laryngeal tube
Measured: through study completion, an average of 360 seconds
hemodynamics Freq
changes in heart frequency (bpm)
Measured: through study completion, an average of 360 seconds
hemodynamics rO2
changes in cerebral oxygenation (percent)
Measured: through study completion, an average of 360 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start13 Aug 2019
- Primary completion30 Mar 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942809
- Sponsor's protocol ID
- JohannesGU-iLT
- Acronym
- iLTS-D2
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability
- ClinicalTrials.gov ID
- NCT03942809
- Acronym / sponsor ID
- iLTS-D2 / JohannesGU-iLT
- Conditions
- Airway Management
- Keywords
- Airway Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 8 May 2019 (actual)
- 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.
A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.
Detailed description
The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effectiveness | Experimental | Device: EffectivenessEvaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective surgery patients under general Anesthesia
Key exclusion criteria (5 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
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 |
|---|---|---|
| EffectivenessEffectiveness and Practicability in anesthetized patient under controlled conditions | Device | Effectiveness |
Primary outcome
Insertion time LT
Time frame: in 30 seconds
Insertion of the laryngeal tube
5 secondary outcomes
Insertion time ET
Time frame: in 60 seconds
Rate of successful Intubation attempts
Time frame: through study completion, an average of 120 seconds
hemodynamics MAP
Time frame: through study completion, an average of 360 seconds
hemodynamics Freq
Time frame: through study completion, an average of 360 seconds
hemodynamics rO2
Time frame: through study completion, an average of 360 seconds
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 28 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Marc Kriege, MD principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effectiveness in people with Airway Management, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 5 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 28 Apr 2020. 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 Germany. 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?
Insertion time LT (time frame: in 30 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 28 Apr 2020.