Cardiopulmonary ArrestNCT01452867
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
A study testing Bag-Valve-Mask-Ventilation (Ambu Facemask), Laryngeal Mask (Laryngeal Mask Airway Supreme) and Laryngeal Tube (Laryngeal Tube LT-S-D (VBM)) in people with Cardiopulmonary Arrest, run by Krankenhaus Bruneck at 1 site in Italy.
Trial summary
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- Bag-Valve-Mask-Ventilation (Ambu Facemask), Laryngeal Mask (Laryngeal Mask Airway Supreme) and Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Oct 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- -> 18 years old
- elective surgery in general anesthesia
Who cannot join
- Patient not sober
- BMI > 35kg/m2
- Pathologies of cerebral spine or peripheral neurological deficit
- Hiatus hernia, history of gastric reflux
- Stomach or Esophagus -Operation in the medical history
- Acute respiratory infection or obstructive lung disease
- Non elective surgery
- facial deformity
Trial locations and contacts
1 site in 1 country.
About this study
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.
Read the detailed description
During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- Bag-Valve-Mask-Ventilation (Ambu Facemask), Laryngeal Mask (Laryngeal Mask Airway Supreme), Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
- Keywords
- Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag-Valve-Mask-Ventilation (Ambu Facemask)Device
Also called Ambu Facemask
Bag-Valve Mask-Ventilation
Laryngeal Mask (Laryngeal Mask Airway Supreme)Device
Also called Laryngeal Mask Airway Supreme
Ventilation
Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))Device
Also called Laryngeal Tube LT-S-D (VBM)
Ventilation
| Study group | Role | What they receive |
|---|---|---|
| Bag-Mask-Ventilation | Active comparator | Bag-Valve Mask-Ventilation in 50 patients in general anesthesia Receives: Device: Bag-Valve-Mask-Ventilation (Ambu Facemask) |
| Laryngeal Mask Ventilation | Active comparator | Laryngeal Mask Ventilation in 50 patients in general anesthesia Receives: Device: Laryngeal Mask (Laryngeal Mask Airway Supreme) |
| Laryngeal Tube Ventilation | Active comparator | Laryngeal Tube Ventilation in 50 patients in general anesthesia Receives: Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Management time until first effective Ventilation
Effective Ventilation within 90 Seconds required
Measured: 90 sec
Secondary outcomes (1)
Stomach inflation
Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask
Measured: 60 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ArrestStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Bruneck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Principal investigator, Gruber Elisabeth, Krankenhaus Bruneck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452867
- Sponsor's protocol ID
- BLS VENT 2011/04
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
- ClinicalTrials.gov ID
- NCT01452867
- Acronym / sponsor ID
- BLS VENT 2011/04
- Conditions
- Cardiopulmonary Arrest
- Keywords
- Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Krankenhaus BruneckUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Oct 2011 (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.
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.
Detailed description
During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bag-Mask-Ventilation | Active comparator | Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)Bag-Valve Mask-Ventilation in 50 patients in general anesthesia |
| Laryngeal Mask Ventilation | Active comparator | Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)Laryngeal Mask Ventilation in 50 patients in general anesthesia |
| Laryngeal Tube Ventilation | Active comparator | Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))Laryngeal Tube Ventilation in 50 patients in general anesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- -> 18 years old
- elective surgery in general anesthesia
Key exclusion criteria (8 listed)
- Patient not sober
- BMI > 35kg/m2
- Pathologies of cerebral spine or peripheral neurological deficit
- Hiatus hernia, history of gastric reflux
- Stomach or Esophagus -Operation in the medical history
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-Ventilation (Ambu Facemask)Also: Ambu FacemaskBag-Valve Mask-Ventilation | Device | Bag-Mask-Ventilation |
| Laryngeal Mask (Laryngeal Mask Airway Supreme)Also: Laryngeal Mask Airway SupremeVentilation | Device | Laryngeal Mask Ventilation |
| Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))Also: Laryngeal Tube LT-S-D (VBM)Ventilation | Device | Laryngeal Tube Ventilation |
Primary outcome
Airway Management time until first effective Ventilation
Time frame: 90 sec
Effective Ventilation within 90 Seconds required
1 secondary outcome
Stomach inflation
Time frame: 60 sec
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 17 Oct 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bag-Valve-Mask-Ventilation (Ambu Facemask), Laryngeal Mask (Laryngeal Mask Airway Supreme) and Laryngeal Tube (Laryngeal Tube LT-S-D (VBM)) in people with Cardiopulmonary Arrest, run by Krankenhaus Bruneck at 1 site in Italy.
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 3 inclusion and 8 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 17 Oct 2011. 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 Italy. 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?
Airway Management time until first effective Ventilation (time frame: 90 sec). 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 17 Oct 2011.