Mechanical Ventilation
Conditions
Brief summary
The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.
Interventions
OTHERVentCoach
VentCoach, a mechanical power-guided lung protective ventilation protocol, will be used to set ventilator adjustments. VentCoach ventilator assessments and adjustments will be performed within one hour after enrollment, and then every 4 hours thereafter
OTHERStandard of Care
Intubated patients will be managed per the standard of care ARDSnet-based mechanical ventilation management at Mayo Clinic, with routine RT/MD assessments, and ventilator setting changes as necessary for the treatment of the patient.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with acute hypoxemic and/or hypercapnic respiratory failure. * Patients requiring intubation and mechanical ventilation for more than 24 hours. * VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV). * Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs. * Age greater than or equal to 18 years. * Patient's legal representative should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
Exclusion criteria
* Intubation and mechanical ventilation for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy. * Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours. * Intubation and mechanical ventilation in the setting of cardiac arrest. * Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc. * Mechanical ventilation to be guided by esophageal balloon. * Subject deprived of freedom, minor, subject under a legal protective measure. * Change in end-of-life decision anticipated after enrollment (or estimated 6-month mortality rate of greater than 50%). Note: prone positioning is not a contraindication for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the VentCoach protocol | 1 year | Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to removal from ventilator | 1 year | Time to successful extubation, allocation to ECMO, or death reported in number of days |
| Incidence of patient-ventilator dyssynchrony | 1 year | Number of patients to experience patient-ventilator dyssynchrony, defined as double triggering and flow starvation |
| Overall use of sedation | 1 year | Total use of analgesia, converted to morphine equivalent |
| Overall use of paralytics | 1 year | Total number of patients to require paralytics: bolus and infusion of neuromuscular blockade outside intubation procedure |
| Oxygenation index | Baseline, end of treatment (up to 14 days) | Oxygenation index is calculated by the following equation: mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 and is reported as a single number. |
Countries
United States
Outcome results
None listed