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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: Clinical Trial NA study, sponsored by Brigham and Women's Hospital.

NCT03512067 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Total number of asynchronous breaths/hour during entrainment-based ventilation compared to baseline ventilation.

Interventions

  • DEVICE Patients given EMV Ventilation

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2018-08-01
Est. Completion 2018-09-02
Phase NA
Brigham and Women's Hospital

937 total trials

Why NCT03512067 stopped before completion

NCT03512067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Patients given EMV Ventilation is the first listed.

NCT03512067 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03512067's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03512067, the US trial registry maintained by the National Library of Medicine. NCT03512067 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.