Respiration, ArtificialiVentNCT00652756
Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation
A study testing Use of ventilator during patient transport (Versamed iVent) and Bag-valve ventilation in people with Respiration, Artificial, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport and reduce transport-associated complications while providing equivalent ventilatory support and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Use of ventilator during patient transport (Versamed iVent) and Bag-valve ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Feb 2012
- 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
- Patients eligible for the trial will be receiving mechanical ventilation in the emergency department, critical care, and other patient care areas; and will require transport within the hospital.
Who cannot join
- Patient must be at least eighteen years of age.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport and reduce transport-associated complications while providing equivalent ventilatory support and transport success rates for both intubated patients and patients receiving noninvasive ventilation.
Read the detailed description
Transporting acute-care patients who require mechanical ventilation within a hospital can be fraught with hazards. Prior studies have revealed a high level of transport-associated complications including episodes of hypertension, hypoxemia, respiratory arrest, and death (1). In many institutions, the preferred method of transporting intubated patients is to use manual ventilation with a resuscitator bag, an approach that fully occupies one member of the transport team. Using a transport ventilator involves taking an intubated patient who has been placed on one ventilator and switching the patient to the transport ventilator; until now, transport ventilators had not been designed to match the capabilities of the more robustly engineered critical care ventilators.
The use of noninvasive ventilation (NIV) to treat patients with COPD exacerbations and other forms of respiratory failure has increased because of its demonstrated efficacy in reducing the need for intubation as well as morbidity and mortality (2). None of the ventilators usually used for noninvasive ventilation was designed for in-patient transport.
Currently, the standard of care in this institution is to transport intubated patients receiving mechanical ventilation by using a manual resuscitation bag and to transport patients receiving NIV by placing the patient on oxygen therapy without ventilatory support.
The VersaMed iVent ventilator was designed to treat respiratory failure in the acute care setting. The device is suitable for patients who are intubated as well as for patients receiving noninvasive ventilation, has a backup battery so that it can function during transport, and has been approved by the FDA for invasive and noninvasive mechanical ventilation. This device permits continuity of mechanical ventilation virtually regardless of patient status.
We propose to evaluate the utility of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport, reduce transport-associated complications, and provide equivalent ventilatory support and transport-success rates for both intubated patients and patients receiving NIV.
References
- Braman SS, Dunn SM, Amico CA, Millman RP. Complications of intrahospital transport in critically ill patients. Ann Intern Med 1987; 107:469-73.
- Mehta S, Hill NS. Noninvasive ventilation-state of the art. Am J Respir Crit Care Med 2001; Feb; 163(2):540-77.
- Conditions
- Respiration, Artificial
- Being tested
- Use of ventilator during patient transport (Versamed iVent), Bag-valve ventilation
- Keywords
- Respiration, Artificial, Transportation of Patients, Intubation, Intratracheal, Tracheostomy
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ventilator during patient transport (Versamed iVent)Device
Also called Versamed iVent ventilator
The goal of the transport ventilator is to provide optimal ventilation.
Bag-valve ventilationOther
Also called Use of manual resuscitator during transport.
Use of bag-valve ventilation during patient transport.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient is placed on a transport ventilator. Receives: Device: Use of ventilator during patient transport (Versamed iVent) |
| 2 | Other | Patient is ventilated using the current standard at this institution. Receives: Other: Bag-valve ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether using a ventilator during patient transport has better outcomes than the current approach to transport.
Measured: One year (estimated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Unable to recruit adequately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas S. Hill, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652756
- Sponsor's protocol ID
- 7299
- Other IDs
- 000
- Acronym
- iVent
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2008
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00652756
- Acronym / sponsor ID
- iVent / 7299
- Conditions
- Respiration, Artificial
- Keywords
- Respiration, Artificial, Transportation of Patients, Intubation, Intratracheal, Tracheostomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit adequately
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Apr 2008 (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.
The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport and reduce transport-associated complications while providing equivalent ventilatory support and transport success rates for both intubated patients and patients receiving noninvasive ventilation.
Detailed description
Transporting acute-care patients who require mechanical ventilation within a hospital can be fraught with hazards. Prior studies have revealed a high level of transport-associated complications including episodes of hypertension, hypoxemia, respiratory arrest, and death (1). In many institutions, the preferred method of transporting intubated patients is to use manual ventilation with a resuscitator bag, an approach that fully occupies one member of the transport team. Using a transport ventilator involves taking an intubated patient who has been placed on one ventilator and switching the patient to the transport ventilator; until now, transport ventilators had not been designed to match the capabilities of the more robustly engineered critical care ventilators.
The use of noninvasive ventilation (NIV) to treat patients with COPD exacerbations and other forms of respiratory failure has increased because of its demonstrated efficacy in reducing the need for intubation as well as morbidity and mortality (2). None of the ventilators usually used for noninvasive ventilation was designed for in-patient transport.
Currently, the standard of care in this institution is to transport intubated patients receiving mechanical ventilation by using a manual resuscitation bag and to transport patients receiving NIV by placing the patient on oxygen therapy without ventilatory support.
The VersaMed iVent ventilator was designed to treat respiratory failure in the acute care setting. The device is suitable for patients who are intubated as well as for patients receiving noninvasive ventilation, has a backup battery so that it can function during transport, and has been approved by the FDA for invasive and noninvasive mechanical ventilation. This device permits continuity of mechanical ventilation virtually regardless of patient status.
We propose to evaluate the utility of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport, reduce transport-associated complications, and provide equivalent ventilatory support and transport-success rates for both intubated patients and patients receiving NIV.
References
- Braman SS, Dunn SM, Amico CA, Millman RP. Complications of intrahospital transport in critically ill patients. Ann Intern Med 1987; 107:469-73.
- Mehta S, Hill NS. Noninvasive ventilation-state of the art. Am J Respir Crit Care Med 2001; Feb; 163(2):540-77.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Use of ventilator during patient transport (Versamed iVent)Patient is placed on a transport ventilator. |
| 2 | Other | Other: Bag-valve ventilationPatient is ventilated using the current standard at this institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for the trial will be receiving mechanical ventilation in the emergency department, critical care, and other patient care areas; and will require transport within the hospital.
Key exclusion criteria (1 listed)
- Patient must be at least eighteen years of age.
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 |
|---|---|---|
| Use of ventilator during patient transport (Versamed iVent)Also: Versamed iVent ventilatorThe goal of the transport ventilator is to provide optimal ventilation. | Device | 1 |
| Bag-valve ventilationAlso: Use of manual resuscitator during transport.Use of bag-valve ventilation during patient transport. | Other | 2 |
Primary outcome
To determine whether using a ventilator during patient transport has better outcomes than the current approach to transport.
Time frame: One year (estimated)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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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.
Nicholas S. Hill, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ventilator during patient transport (Versamed iVent) and Bag-valve ventilation in people with Respiration, Artificial, run by Tufts Medical Center 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 1 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: withdrawn, as of the sponsor's last update on 6 Apr 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine whether using a ventilator during patient transport has better outcomes than the current approach to transport. (time frame: One year (estimated)). 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 6 Apr 2017.