Ventilation Therapy; ComplicationsNCT03542747
Comparison of iLTS and LMA Fastrach in a Simulated Airway.
A study testing Time to ventilation with the iLTS and Time to ventilation with the Fastrach in people with Ventilation Therapy; Complications, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- Time to ventilation with the iLTS and Time to ventilation with the Fastrach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 28 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical students
- Present written informed consent of the research participant
Who cannot join
- inability to consent
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: Comparison of the Novel iLTS and Fastrach Intubation Laryngeal Mask for Time to Ventilation in a Simulated Airway.
Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach
Read the detailed description
Prior to the study every participant obtained a standardized instruction of each device. In the proposed clinical trial the primary study objective will be to determine whether there is a difference in time to ventilation via endotracheal tube (seconds) for the novel iLTS-D compared to the LMA Fastrach. Time to Ventilation will be defined from when the tip of the extraglottic airway device passed the incisors to the point until confirmation the first chest rise of the high fidelity simulator (Laerdal SimMan). Additionally, two time points before final tracheal placement will evaluated: time to place the EGA and time to ventilate with the EGA after introducing the device into the oral cavity.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- Time to ventilation with the iLTS, Time to ventilation with the Fastrach
- Keywords
- Airway, extraglottic, simulation, laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to ventilation with the iLTSDevice
Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
Time to ventilation with the FastrachDevice
Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds
| Study group | Role | What they receive |
|---|---|---|
| Time to ventilation with the iLTS | Experimental | Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds Receives: Device: Time to ventilation with the iLTS; Device: Time to ventilation with the Fastrach |
| Time to ventilation with the Fastrach | Experimental | Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds Receives: Device: Time to ventilation with the iLTS; Device: Time to ventilation with the Fastrach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ventilation via endotracheal tube
time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise
Measured: 0 to 300 seconds
Secondary outcomes (3)
Time to ventilation via extraglottic airway device
time to ventilation will defined from when the device tip passed the incisors to the point until the first chest rise
Measured: 0 to 300 seconds
Intubation attempts
Numbers of successful intubation attempts (1-5 attempts)
Measured: 0 to 300 seconds
Ease of Insertion
Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)
Measured: 0 to 420 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jun 2018
- Primary completion28 Sep 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 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
- Thomas Ott, MD, Study director, Johannes GU, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542747
- Sponsor's protocol ID
- JohannesGUN
- Status last verified
- Apr 2019
- First submitted
- 20 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. No abstract available.
PubMed 29233740Ott T, Fischer M, Limbach T, Schmidtmann I, Piepho T, Noppens RR. The novel intubating laryngeal tube (iLTS-D) is comparable to the intubating laryngeal mask (Fastrach) - a prospective randomised manikin study. Scand J Trauma Resusc Emerg Med. 2015 Jun 8;23:44. doi: 10.1186/s13049-015-0126-y.
PubMed 26051498Ott T, Tschope K, Toenges G, Buggenhagen H, Engelhard K, Kriege M. Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study. BMC Anesthesiol. 2020 May 11;20(1):111. doi: 10.1186/s12871-020-01029-3.
PubMed 32393169
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Novel iLTS and Fastrach Intubation Laryngeal Mask for Time to Ventilation in a Simulated Airway.
- ClinicalTrials.gov ID
- NCT03542747
- Acronym / sponsor ID
- JohannesGUN
- Conditions
- Ventilation Therapy; Complications
- Keywords
- Airway, extraglottic, simulation, laryngeal mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 31 May 2018 (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.
Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach
Detailed description
Prior to the study every participant obtained a standardized instruction of each device. In the proposed clinical trial the primary study objective will be to determine whether there is a difference in time to ventilation via endotracheal tube (seconds) for the novel iLTS-D compared to the LMA Fastrach. Time to Ventilation will be defined from when the tip of the extraglottic airway device passed the incisors to the point until confirmation the first chest rise of the high fidelity simulator (Laerdal SimMan). Additionally, two time points before final tracheal placement will evaluated: time to place the EGA and time to ventilate with the EGA after introducing the device into the oral cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time to ventilation with the iLTS | Experimental | Device: Time to ventilation with the iLTS, Device: Time to ventilation with the FastrachMeasuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds |
| Time to ventilation with the Fastrach | Experimental | Device: Time to ventilation with the iLTS, Device: Time to ventilation with the FastrachMeasuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical students
- Present written informed consent of the research participant
Key exclusion criteria (1 listed)
- inability to consent
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 |
|---|---|---|
| Time to ventilation with the iLTSTime to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds | Device | Time to ventilation with the Fastrach, Time to ventilation with the iLTS |
| Time to ventilation with the FastrachTime to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds | Device | Time to ventilation with the Fastrach, Time to ventilation with the iLTS |
Primary outcome
Time to ventilation via endotracheal tube
Time frame: 0 to 300 seconds
time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise
3 secondary outcomes
Time to ventilation via extraglottic airway device
Time frame: 0 to 300 seconds
Intubation attempts
Time frame: 0 to 300 seconds
Ease of Insertion
Time frame: 0 to 420 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 16 Apr 2019.
- Background: PubMed 29233740Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. No abstract available.
- Results publication: PubMed 26051498Ott T, Fischer M, Limbach T, Schmidtmann I, Piepho T, Noppens RR. The novel intubating laryngeal tube (iLTS-D) is comparable to the intubating laryngeal mask (Fastrach) - a prospective randomised manikin study. Scand J Trauma Resusc Emerg Med. 2015 Jun 8;23:44. doi: 10.1186/s13049-015-0126-y.
- Derived from this study: PubMed 32393169Ott T, Tschope K, Toenges G, Buggenhagen H, Engelhard K, Kriege M. Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study. BMC Anesthesiol. 2020 May 11;20(1):111. doi: 10.1186/s12871-020-01029-3.
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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.
Thomas Ott, MD study director
Johannes GU, 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 Time to ventilation with the iLTS and Time to ventilation with the Fastrach in people with Ventilation Therapy; Complications, 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 2 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 16 Apr 2019. 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?
Time to ventilation via endotracheal tube (time frame: 0 to 300 seconds). 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 NCT03542747, which also lists 3 linked publications.
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 16 Apr 2019.