Trilogy Comparison Study - Pediatrics

Philips

Status: Completed

Conditions: Respiratory Failure

Treatments: Device: Trilogy Ventilator; Device: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810459

MR-0713-PTRI-SS

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 6 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

6 participants in 2 patient groups

Trilogy ventilator

Experimental group

Description:

Trilogy ventilator

Treatment:

Device: Trilogy Ventilator

Standard of Care

Active Comparator group

Description:

Participants currently prescribed ventilator

Treatment:

Device: Standard of Care