Respiratory FailureNCT04369274
Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Vent
A study testing Mechanical ventilation with the automated BVM compressor in people with Respiratory Failure, run by Massachusetts General Hospital.
Trial summary
The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (BVM) compressor, can be used to provide assisted ventilation temporarily to patients in need. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Mechanical ventilation with the automated BVM compressor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient may be diagnosed with Covid-19 based on clinical presentation and available laboratory studies including specific Covid-19 testing.
- Patient with imminent respiratory failure or status post respiratory failure receiving mechanical ventilation, or requiring mechanical ventilation for airway protection or other cause.
- Evidence of no pulmonary disease, or mild to moderate ARDS based on:
- fraction of inspired oxygen (FiO2) ≤ 60% with arterial oxygen saturation > 90%
- positive end expiratory pressure (PEEP) ≤ 12 cm H20
- Using an adaptive trial design, the first 10 patients must require mechanical ventilation for reasons other than COVID-19 infection such as airway protection due to overdose, seizure, stroke, or trauma. The next 10 patients may have COVID-19 infection, but must demonstrate lung compliance ≥ 40 ml/cm H2O. If these 10 patients demonstrate a satisfactory course associated with treatment, then the final 10 patients may have lung compliance ≥ 30 ml/cm H2O. Satisfactory treatment course will include, at a minimum: oxygen saturation > 90%, with PEEP ≤ 12 cm H2O.
Who cannot join
- Lack of informed consent from patient, if deemed having capacity, or from surrogate if not
- Too medically unstable to participate in study per treating clinician
- Patients requiring more than one vasopressor medication for blood pressure support
- Age > 65 years
- Clinical evidence of acute coronary syndrome (ACS) including angina, or ECG evidence of acute ischemia or dysrhythmia
- Chronic lung disease including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or pulmonary hypertension
Show all 12Show fewer
- Gross laboratory abnormalities including, when available: liver function tests (LFT) > 5x normal, C-reactive protein (CRP) > 200 mg/L, ferritin > 2000 µg/L, creatine phosphokinase (CPK) > 3x normal, D-Dimer > 2500 ng/ml
- Previously enrolled subject
- Children
- Pregnant women
- Estimated body mass index (BMI) greater than 30
- Prisoners
About this study
Official title: A Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Ventilation for the Treatment of COVID-19 ARDS
The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (BVM) compressor, can be used to provide assisted ventilation temporarily to patients in need. This includes patients with COVID-19 lung infection and respiratory failure. If successful, this would increase the pool of total available ventilator hours to alleviate any shortage.
Read the detailed description
This study will be performed in the emergency department and ICU's of Massachusetts General Hospital (MGH). Thirty patients requiring mechanical ventilation will be enrolled. The design is a case series with repeated measures analysis. All patients will receive the experimental treatment as well as conventional ventilation and unassisted oxygenation as observed prior to initiation of mechanical ventilation. The compressor used will be manufactured by Spiro LLC / 10xbeta based on the open source MIT design. The device is powered by an uninterrupted power supply from a standard electrical outlet and it alarms if unplugged.
The patient will be moved into a negative pressure room. After patients with respiratory failure are intubated and stabilized on a conventional ventilator, they will receive 15 minutes of artificial respirations with the automated compressor with the conventional ventilator standing by. They will be returned to the conventional respirator after this period, or sooner if necessary. The endotracheal tube will be briefly clamped during the rapid transition from one device to another to minimize aerosolization of any viral particles and to retain any PEEP.
If the initial study period demonstrates successful respiratory support, then the procedure may be repeated once with doubling of the automated compressor treatment time to 30 minutes. There will be a minimum 15-minute observation period with conventional mechanical ventilation between the two study periods. Additionally, there will be one hour of data collection after the study periods. The total duration of the two intervention periods, the intervening period and data collection is two hours. The primary outcome is arterial oxygenation.
Patients are chemically paralyzed to facilitate intubation as part of standard care. Rocuronium is typically used for intubating chemical paralysis in the MGH emergency department. It has a half-life of 66 minutes. A single repeat bolus will be provided if needed to ensure chemical paralysis for the duration of the study. If the patient is already intubated and no longer chemically paralyzed, than one bolus of rocuronium, and a second as needed, or just a temporary increase in ongoing sedation will be provided to minimize spontaneous respiration. The airway circuit will be continuously monitored with a separate pressure and flow monitor (Nico) with recorded digital output throughout the experiment.
- Conditions
- Respiratory Failure
- Being tested
- Mechanical ventilation with the automated BVM compressor
- Keywords
- mechanical ventilator
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation with the automated BVM compressorDevice
Mechanical ventilation is accomplished with a device that mechanically squeezes a manual bag valve instead of by hand. The rate and volume of compression are adjustable, and the device has appropriate alarms and safety features.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All subjects will briefly be placed on the automated BVM compressor device. Measurements obtained while on this device will be compared to those obtained in the same subject prior to mechanical ventilation and while on a conventional ventilator. Receives: Device: Mechanical ventilation with the automated BVM compressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygenation
Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.
Measured: Measurement 10 minutes after onset of initial period of automatic compressed ventilations
Arterial oxygenation
Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.
Measured: Measurement 20 minutes after onset of second period of automatic compressed ventilations
Secondary outcomes (5)
Expired pressure of carbon dioxide.
Expired carbon dioxide (CO2) pressure will be measured continuously with a monitor in the airway circuit.
Measured: 2 hour total study period.
Airway pressure
The pressure (cm H2O) of inspired and expired air in the airway circuit while the subject is mechanically ventilated will be measured continuously using a Nico monitor.
Measured: 2 hour total study period.
Heart rate
Subject heart rate (beats per minute) will be measured continuously using a telemetry monitor,
Measured: 2 hour total study period.
Blood pressure
Subject blood pressure (mm Hg) will be measured episodically every 5 minutes using an automated arm cuff.
Measured: 2 hour total study period.
Airway flow
The flow (L/min) of inspired and expired air in the airway circuit while the subject is mechanically ventilated will be measured continuously using a Nico monitor.
Measured: 2 hour total study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study startAug 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: The epidemic of Covid pneumonia requiring large scale mechanical ventilation has abated and the need to explore alternate ventilatory devices has resolved.
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 Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The design is a case series with repeated measures analysis. All patients will receive the experimental treatment as well as conventional ventilation and unassisted oxygenation as observed prior to initiation of mechanical ventilation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Marill, Massachusetts General Hospital
- Investigators
- Keith A Marill, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369274
- Sponsor's protocol ID
- 2020P001051
- Status last verified
- Mar 2023
- First submitted
- 23 Apr 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Al Husseini AM, Lee HJ, Negrete J, Powelson S, Servi AT, Slocum AH, Saukkonen J. Design and Prototyping of a Low-Cost Portable Mechanical Ventilator. J Med Device. 2010 Jun 1;4(2):027514. doi: 10.1115/1.3442790. Epub 2010 Aug 9.
PubMed 32328214
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Ventilation for the Treatment of COVID-19 ARDS
- ClinicalTrials.gov ID
- NCT04369274
- Acronym / sponsor ID
- 2020P001051
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilator
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The epidemic of Covid pneumonia requiring large scale mechanical ventilation has abated and the need to explore alternate ventilatory devices has resolved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 30 Apr 2020 (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.
The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (BVM) compressor, can be used to provide assisted ventilation temporarily to patients in need. This includes patients with COVID-19 lung infection and respiratory failure. If successful, this would increase the pool of total available ventilator hours to alleviate any shortage.
Detailed description
This study will be performed in the emergency department and ICU's of Massachusetts General Hospital (MGH). Thirty patients requiring mechanical ventilation will be enrolled. The design is a case series with repeated measures analysis. All patients will receive the experimental treatment as well as conventional ventilation and unassisted oxygenation as observed prior to initiation of mechanical ventilation. The compressor used will be manufactured by Spiro LLC / 10xbeta based on the open source MIT design. The device is powered by an uninterrupted power supply from a standard electrical outlet and it alarms if unplugged.
The patient will be moved into a negative pressure room. After patients with respiratory failure are intubated and stabilized on a conventional ventilator, they will receive 15 minutes of artificial respirations with the automated compressor with the conventional ventilator standing by. They will be returned to the conventional respirator after this period, or sooner if necessary. The endotracheal tube will be briefly clamped during the rapid transition from one device to another to minimize aerosolization of any viral particles and to retain any PEEP.
If the initial study period demonstrates successful respiratory support, then the procedure may be repeated once with doubling of the automated compressor treatment time to 30 minutes. There will be a minimum 15-minute observation period with conventional mechanical ventilation between the two study periods. Additionally, there will be one hour of data collection after the study periods. The total duration of the two intervention periods, the intervening period and data collection is two hours. The primary outcome is arterial oxygenation.
Patients are chemically paralyzed to facilitate intubation as part of standard care. Rocuronium is typically used for intubating chemical paralysis in the MGH emergency department. It has a half-life of 66 minutes. A single repeat bolus will be provided if needed to ensure chemical paralysis for the duration of the study. If the patient is already intubated and no longer chemically paralyzed, than one bolus of rocuronium, and a second as needed, or just a temporary increase in ongoing sedation will be provided to minimize spontaneous respiration. The airway circuit will be continuously monitored with a separate pressure and flow monitor (Nico) with recorded digital output throughout the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design is a case series with repeated measures analysis. All patients will receive the experimental treatment as well as conventional ventilation and unassisted oxygenation as observed prior to initiation of mechanical ventilation.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Mechanical ventilation with the automated BVM compressorAll subjects will briefly be placed on the automated BVM compressor device. Measurements obtained while on this device will be compared to those obtained in the same subject prior to mechanical ventilation and while on a conventional ventilator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient may be diagnosed with Covid-19 based on clinical presentation and available laboratory studies including specific Covid-19 testing.
- Patient with imminent respiratory failure or status post respiratory failure receiving mechanical ventilation, or requiring mechanical ventilation for airway protection or other cause.
- Evidence of no pulmonary disease, or mild to moderate ARDS based on:
- Using an adaptive trial design, the first 10 patients must require mechanical ventilation for reasons other than COVID-19 infection such as airway protection due to overdose, seizure, stroke, or trauma. The next 10 patients may have COVID-19 infection, but must demonstrate lung compliance ≥ 40 ml/cm H2O. If these 10 patients demonstrate a satisfactory course associated with treatment, then the final 10 patients may have lung compliance ≥ 30 ml/cm H2O. Satisfactory treatment course will include, at a minimum: oxygen saturation > 90%, with PEEP ≤ 12 cm H2O.
Key exclusion criteria (12 listed)
- Lack of informed consent from patient, if deemed having capacity, or from surrogate if not
- Too medically unstable to participate in study per treating clinician
- Patients requiring more than one vasopressor medication for blood pressure support
- Age > 65 years
- Clinical evidence of acute coronary syndrome (ACS) including angina, or ECG evidence of acute ischemia or dysrhythmia
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 |
|---|---|---|
| Mechanical ventilation with the automated BVM compressorMechanical ventilation is accomplished with a device that mechanically squeezes a manual bag valve instead of by hand. The rate and volume of compression are adjustable, and the device has appropriate alarms and safety features. | Device | Interventional |
Primary outcome
Arterial oxygenation
Time frame: Measurement 10 minutes after onset of initial period of automatic compressed ventilations
Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.
Arterial oxygenation
Time frame: Measurement 20 minutes after onset of second period of automatic compressed ventilations
Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.
5 secondary outcomes
Expired pressure of carbon dioxide.
Time frame: 2 hour total study period.
Airway pressure
Time frame: 2 hour total study period.
Heart rate
Time frame: 2 hour total study period.
Blood pressure
Time frame: 2 hour total study period.
Airway flow
Time frame: 2 hour total study period.
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 15 Mar 2023.
- Background: PubMed 32328214Al Husseini AM, Lee HJ, Negrete J, Powelson S, Servi AT, Slocum AH, Saukkonen J. Design and Prototyping of a Low-Cost Portable Mechanical Ventilator. J Med Device. 2010 Jun 1;4(2):027514. doi: 10.1115/1.3442790. Epub 2010 Aug 9.
- Individual participant dataSharing planned: No
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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.
Keith A Marill, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation with the automated BVM compressor in people with Respiratory Failure, run by Massachusetts General Hospital.
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 6 inclusion and 12 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Arterial oxygenation (time frame: Measurement 10 minutes after onset of initial period of automatic compressed ventilations). The study lists 2 primary outcomes in all. 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 NCT04369274, 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 15 Mar 2023.