Entrainment-Based Mechanical Ventilation
Stopped early · Not applicable
Conditions studied: Respiratory Insufficiency, Respiratory Failure, Mechanical Ventilation Complication
In brief
BACKGROUND AND SIGNIFICANCE Entrainment-based ventilation is a new mode of mechanical ventilation based on the classical physics theory of mutual entrainment between coupled oscillators. Typically, the entrained inspiratory activity may precede or lag behind machine inflation depending on whether spontaneous respiratory frequency is higher or lower than the ventilator frequency. HYPOTHESIS The investigators anticipate that the results of the study will help to improve the interaction of patients with the mechanical ventilator thereby minimizing the risks of mechanical ventilation in future. The investigators believe the potential benefits significantly outweigh the potential risks. RESEARCH STUDY DESIGN AND METHODS This is a prospective study and single site. Twenty mechanically ventilated patients, stable on their current vent settings and are capable of triggering the ventilator in the SICU, MICU, CCU and Cardiac and Neuro Surgery ICUs at BWH will be recruited. After obtaining informed consent a respiratory real-time data monitor will be placed between the artificial airway and the Y piece of the ventilator circuit. Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized. DATA COLLECTION Demographic data, weight, height, and past and current medical history will be recorded. Also hospital admission information, reasons of mechanical ventilation, mode of mechanical ventilation and settings, arterial blood gas, clinical laboratory (hematology/chemistry) values, and hemodynamic values will be recorded. STATISTICAL ANALYSIS Baseline demographic and procedural variables will be analyzed statistically by plotting the 95% confidence intervals of each variable. For feasibility evaluation, the total number of each type of asynchronous breaths/hour during entrainment-based ventilation will be averaged over the 4-hour experimental period and compared with those in the 4-hour baseline ventilation period.
Key facts
- Study ID
- NCT03512067
- Run by
- Brigham and Women's Hospital
- People needed
- 1
- Starts
- 2018-08-01
- Expected to finish
- 2018-09-02
- Last updated by the study team
- 2019-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult (at least 18 years of age), mechanically ventilated via endotracheal tube, of either sex
- Capable of triggering the ventilator
- Subject receiving pressure support ventilation (or assist/control pressure-limited mechanical ventilation) with less than or equal to 15 cm H2O inspiratory pressure, or, if on volume-limited A/C, when switched to pressure-limited A/C with the inspiratory pressure set to match the tidal volume on volume-limited A/C, the resultant inspiratory pressure is less than or equal to 15 cm H2O.
- Stable on the above-mentioned ventilatory support for at least 8 hours.
- Arterial line in place for obtaining arterial blood gases
You may not qualify if…
- Requiring high inspiratory oxygen concentration (> 50%).
- Requiring high ventilatory driving pressure (> 15 cm H20 on pressure-support)
- High spinal cord injury
- Immunosuppressed, < 2 months after receiving chemotherapy or radiation therapy.
- Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
- High risk of mortality within 3 months (terminal stage of their disease).
- Unable to spontaneously trigger the ventilator for any reason.
- Not considered a candidate for weaning from ventilatory support
- Consented for another interventional study.
- Requiring deep sedation and analgesia [Richmond Agitation Sedation Scale -3 to -5 (RASS)]
- Hemodynamically unstable patients as defined by those requiring norepinephrine at a dose greater than 5 mcg/min or neosynephrine > 100 mcg/min or those with a mean arterial blood pressure < 55 or > 120 mmHg or those with a heart rate < 50 or > 140 bpm.
- Respiratory rate > 30 breaths/min
- Pregnancy
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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