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NCT03512067 · ClinicalTrials.gov registry record · NA
Entrainment-Based Mechanical Ventilation
A NA study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03512067 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 1 participants.
The verdict
NCT03512067, a NA study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
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 dem
Interventions
- DEVICE Patients given EMV Ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2018-09-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03512067
The ClinicalTrials.gov registry entry for NCT03512067 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Patients given EMV Ventilation is the first listed.
NCT03512067 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03512067 about?
NCT03512067 is a clinical study titled "Entrainment-Based Mechanical Ventilation". 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 sp...
What is the current status of trial NCT03512067?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-08-01. Estimated completion is 2018-09-02.
What interventions are being tested in trial NCT03512067?
The interventions under investigation include: Patients given EMV Ventilation (DEVICE).
Who is sponsoring clinical trial NCT03512067?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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