Trilogy Comparison Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-10

Study Completion Date

2009-01-26

Brief Summary

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The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.

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Detailed Description

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A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Trilogy ventilator

Group Type EXPERIMENTAL

Trilogy Ventilator

Intervention Type DEVICE

Exposure to one hour on the Trilog ventilator

Standard of Care

Participants currently prescribed ventilator

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DEVICE

Exposure of one hour on the Participants prescribed ventilator

Interventions

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Trilogy Ventilator

Exposure to one hour on the Trilog ventilator

Intervention Type DEVICE

Standard of Care

Exposure of one hour on the Participants prescribed ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age \> 1years of age; \< 18 years of age
2. Greater than 5 kg
3. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O
4. Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)

Exclusion Criteria

1. Clinically unstable, i.e.,

1. Acute Respiratory Failure
2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
3. Uncontrolled cardiac ischemia or arrhythmias
4. or as otherwise determined inappropriate for the study as determined by the investigator
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No