Cardiac Arrest During and/or Resulting From A ProcedurePhase 4NCT01718795
Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR
A Phase 4 study testing Bag-valve mask or laryngeal tube ventilation in people with Cardiac Arrest During and/or Resulting From A Procedure, run by Michael Baubin, MD at 1 site in Austria.
Trial summary
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest During and/or Resulting From A Procedure
- What is being tested?
- Bag-valve mask or laryngeal tube ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2012to Sep 2015
- Phase
- Phase 4
- 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
- Cardiac arrest
Who cannot join
- Paramedic does not want to use laryngeal tube
- Physician on site before paramedic
- Foreign body airway obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.
Read the detailed description
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR. This study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.
- Being tested
- Bag-valve mask or laryngeal tube ventilation
- Keywords
- Airway, Cardiac Arrest, CPR, Ventilation
- Medical subject headings
- Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag-valve mask or laryngeal tube ventilationDevice
Also called BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation
Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR
| Study group | Role | What they receive |
|---|---|---|
| Bag-valve mask ventilation | Active comparator | Bag-valve mask ventilation during CPR, i.e. traditional ventilation during CPR. Airway management with bag-valve mask ventilation and efficient ventilation: yes or no?
Intervention is "Bag-valve mask ventilation" during CPR Receives: Device: Bag-valve mask or laryngeal tube ventilation |
| Laryngeal Tube | Active comparator | Laryngeal Tube Ventilation during CPR, i.e. the alternative ventilation technique to be compared to the traditional technique. Airway management with laryngeal tube and efficient ventilation: yes or no?
Intervention is "Ventilation through laryngeal tube" during CPR Receives: Device: Bag-valve mask or laryngeal tube ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficient ventilation
Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer.
Measured: From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)
Secondary outcomes (1)
Aspiration
Aspiration will be assessed 24hrs after CPR with bronchoscopy
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Recruiting too slow, down to 1-0 patients per month
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest During and/or Resulting From A ProcedureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Baubin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Baubin, MD, Medical University Innsbruck
- Investigators
- Michael Baubin, Prof. MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718795
- Sponsor's protocol ID
- Prehospital LTS vs. BVM
- Status last verified
- Mar 2016
- First submitted
- 7 Jun 2012
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Fiala A, Lederer W, Neumayr A, Egger T, Neururer S, Toferer E, Baubin M, Paal P. EMT-led laryngeal tube vs. face-mask ventilation during cardiopulmonary resuscitation - a multicenter prospective randomized trial. Scand J Trauma Resusc Emerg Med. 2017 Oct 26;25(1):104. doi: 10.1186/s13049-017-0446-1.
PubMed 29073915
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial
- ClinicalTrials.gov ID
- NCT01718795
- Acronym / sponsor ID
- Prehospital LTS vs. BVM
- Keywords
- Airway, Cardiac Arrest, CPR, Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting too slow, down to 1-0 patients per month
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Michael Baubin, MDUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Oct 2012 (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.
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.
Detailed description
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR. This study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bag-valve mask ventilation | Active comparator | Device: Bag-valve mask or laryngeal tube ventilationBag-valve mask ventilation during CPR, i.e. traditional ventilation during CPR. Airway management with bag-valve mask ventilation and efficient ventilation: yes or no? Intervention is "Bag-valve mask ventilation" during CPR |
| Laryngeal Tube | Active comparator | Device: Bag-valve mask or laryngeal tube ventilationLaryngeal Tube Ventilation during CPR, i.e. the alternative ventilation technique to be compared to the traditional technique. Airway management with laryngeal tube and efficient ventilation: yes or no? Intervention is "Ventilation through laryngeal tube" during CPR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac arrest
Key exclusion criteria (3 listed)
- Paramedic does not want to use laryngeal tube
- Physician on site before paramedic
- Foreign body airway obstruction
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 |
|---|---|---|
| Bag-valve mask or laryngeal tube ventilationAlso: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilationInterventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR | Device | Bag-valve mask ventilation, Laryngeal Tube |
Primary outcome
Efficient ventilation
Time frame: From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)
Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer.
1 secondary outcome
Aspiration
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014
Results and safety
The study was stopped early (reason given: Recruiting too slow, down to 1-0 patients per month). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Derived from this study: PubMed 29073915Fiala A, Lederer W, Neumayr A, Egger T, Neururer S, Toferer E, Baubin M, Paal P. EMT-led laryngeal tube vs. face-mask ventilation during cardiopulmonary resuscitation - a multicenter prospective randomized trial. Scand J Trauma Resusc Emerg Med. 2017 Oct 26;25(1):104. doi: 10.1186/s13049-017-0446-1.
- Individual participant dataSharing planned: Yes
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.
Michael Baubin, Prof. MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bag-valve mask or laryngeal tube ventilation in people with Cardiac Arrest During and/or Resulting From A Procedure, run by Michael Baubin, MD at 1 site in Austria.
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 3 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: stopped early, as of the sponsor's last update on 24 Mar 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruiting too slow, down to 1-0 patients per month). 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?
Efficient ventilation (time frame: From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)). 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 NCT01718795, which also lists 1 linked publication.
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 24 Mar 2016.