Trilogy Comparison Study - Pediatrics

Respiratory Failure Clinical Trial

Official title:

Trilogy Comparison Study - Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810459
• Other study ID #: MR-0713-PTRI-SS
• Status: Completed
• Phase: N/A
• Start date: March 10, 2008
• Est. completion date: January 26, 2009

Study information

• Verified date: January 2021
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 26, 2009
• Est. primary completion date: January 26, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Trilogy Ventilator
Exposure to one hour on the Trilog ventilator
• Standard of Care
Exposure of one hour on the Participants prescribed ventilator

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)	Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)	After one hour of ventilator use
Primary	Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)	Comparable level of gas exchange for SpO^2	After one hour of ventilator use
Secondary	Heart Rate	heart rate as measured by beats per minute	60 minutes
Secondary	Minute Ventilation	Minute ventilation	60 minutes
Secondary	Tidal Volume	Tidal Volume	60 minutes