Entrainment-Based Mechanical Ventilation
Public ClinicalTrials.gov record NCT03512067. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Entrainment-Based Mechanical Ventilation to Improve Patient-Ventilator Synchrony
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03512067
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1 participant
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2018
- Primary completion
- Sep 1, 2018
- Completion
- Sep 1, 2018
- Last update posted
- Sep 10, 2019
2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03512067, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2019 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03512067 live on ClinicalTrials.gov.