Pre-hospital VentilationNCT01477710
Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
A study testing Hold mask, Strap Mask and Airway in people with Pre-hospital Ventilation, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hospital Ventilation
- What is being tested?
- Hold mask, Strap Mask and Airway
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation
- Nurse, respiratory therapist, or physician
- involved in the care of patients requiring ventilation and airway management
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume.
Read the detailed description
To evaluate the ability of caregivers to provide adequate ventilation (respiratory rate and tidal volume) in a model of the upper airway and lungs. Ventilation will be delivered while the mask is held in place by the caregiver, with the mask strapped to the model using the securing device provided with the ventilator, and following placement of a supraglottic airway.
- Conditions
- Pre-hospital Ventilation
- Being tested
- Hold mask, Strap Mask, Airway
- Keywords
- Mechanical ventilation, Tidal volume, Respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hold maskProcedure or surgery
The clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes.
Strap MaskProcedure or surgery
The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes
AirwayProcedure or surgery
The clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hold Mask | Active comparator | The clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Receives: Procedure: Hold mask |
| Strap Mask | Active comparator | The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes Receives: Procedure: Strap Mask |
| Airway | Active comparator | The clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes. Receives: Procedure: Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume
Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.
Measured: 10 minutes per technique, for a total of 30 minutes per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-hospital VentilationStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Rich Branson, M.D., University of Cincinnati
- Investigators
- Richard D Branson, MSc RRT, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477710
- Sponsor's protocol ID
- Branson-2010-01
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2011
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
- ClinicalTrials.gov ID
- NCT01477710
- Acronym / sponsor ID
- Branson-2010-01
- Conditions
- Pre-hospital Ventilation
- Keywords
- Mechanical ventilation, Tidal volume, Respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 12 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume.
Detailed description
To evaluate the ability of caregivers to provide adequate ventilation (respiratory rate and tidal volume) in a model of the upper airway and lungs. Ventilation will be delivered while the mask is held in place by the caregiver, with the mask strapped to the model using the securing device provided with the ventilator, and following placement of a supraglottic airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hold Mask | Active comparator | Procedure: Hold maskThe clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. |
| Strap Mask | Active comparator | Procedure: Strap MaskThe clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes |
| Airway | Active comparator | Procedure: AirwayThe clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary participation
- Nurse, respiratory therapist, or physician
- involved in the care of patients requiring ventilation and airway management
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hold maskThe clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. | Procedure or surgery | Hold Mask |
| Strap MaskThe clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes | Procedure or surgery | Strap Mask |
| AirwayThe clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes. | Procedure or surgery | Airway |
Primary outcome
Tidal Volume
Time frame: 10 minutes per technique, for a total of 30 minutes per participant
Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard D Branson, MSc RRT principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hold mask, Strap Mask and Airway in people with Pre-hospital Ventilation, run by University of Cincinnati at 1 site in United States.
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 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 20 Sep 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tidal Volume (time frame: 10 minutes per technique, for a total of 30 minutes per participant). 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 20 Sep 2024.