Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Vent

NCT04369274 | Withdrawn DMC FDA Device

• 1 other identifier: 2020P001051
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Respiratory Failure

Keywords

mechanical ventilator

Outcome Measures

Primary Outcomes (2)

• Arterial oxygenation

  Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.

  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.

  Measurement 20 minutes after onset of second period of automatic compressed ventilations

Secondary Outcomes (5)

• Expired pressure of carbon dioxide.

  2 hour total study period.

• Airway pressure

  2 hour total study period.

• Heart rate

  2 hour total study period.

• Blood pressure

  2 hour total study period.

• Airway flow

  2 hour total study period.

Other Outcomes (1)

• Mortality

  Duration of hospitalization, up to 2 months

Study Arms (1)

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.

Device: Mechanical ventilation with the automated BVM compressor

Interventions

Mechanical ventilation with the automated BVM compressor DEVICE

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.

Interventional

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (1)

• 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.

  PMID: 32328214 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Keith A Marill, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: August 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share