Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Vent
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|ClinicalTrials.gov Identifier: NCT04369274|
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure||Device: Mechanical ventilation with the automated BVM compressor||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||A Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Ventilation for the Treatment of COVID-19 ARDS|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
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.
Device: Mechanical ventilation with the automated BVM compressor
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.
- 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.
- Expired pressure of carbon dioxide. [ Time Frame: 2 hour total study period. ]Expired carbon dioxide (CO2) pressure will be measured continuously with a monitor in the airway circuit.
- Airway pressure [ Time Frame: 2 hour total study period. ]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.
- Heart rate [ Time Frame: 2 hour total study period. ]Subject heart rate (beats per minute) will be measured continuously using a telemetry monitor,
- Blood pressure [ Time Frame: 2 hour total study period. ]Subject blood pressure (mm Hg) will be measured episodically every 5 minutes using an automated arm cuff.
- Airway flow [ Time Frame: 2 hour total study period. ]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.
- Mortality [ Time Frame: Duration of hospitalization, up to 2 months ]The subject will be followed clinically to assess for recovery and survival or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369274
|Contact: Keith A Marill, MDemail@example.com|
|Contact: Blair Parry, CCRCfirstname.lastname@example.org|
|Principal Investigator:||Keith A Marill, MD||Massachusetts General Hospital|