Trilogy Comparison Study - Pediatrics

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00810459
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Device: Trilogy Ventilator; Device: Standard of Care	N/A

Detailed Description

1. 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.

2. 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Trilogy Comparison Study - Pediatrics
• Actual Study Start Date: Mar 10, 2008
• Actual Primary Completion Date: Jan 26, 2009
• Actual Study Completion Date: Jan 26, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trilogy ventilator Trilogy ventilator	Device: Trilogy Ventilator; Exposure to one hour on the Trilog ventilator
Active Comparator: Standard of Care Participants currently prescribed ventilator	Device: Standard of Care; Exposure of one hour on the Participants prescribed ventilator

Outcome Measures

Primary Outcome Measures

1. Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) [After one hour of ventilator use]

   Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)

2. Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) [After one hour of ventilator use]

   Comparable level of gas exchange for SpO^2

Secondary Outcome Measures

1. Heart Rate [60 minutes]

   heart rate as measured by beats per minute

2. Minute Ventilation [60 minutes]

   Minute ventilation

3. Tidal Volume [60 minutes]

   Tidal Volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.,

2. Acute Respiratory Failure

3. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)

4. Uncontrolled cardiac ischemia or arrhythmias

5. or as otherwise determined inappropriate for the study as determined by the investigator

6. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders

7. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba	Winnipeg	Manitoba	Canada

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Steven Mink, MD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT00810459
• Other Study ID Numbers: MR-0713-PTRI-SS
• First Posted: Dec 18, 2008
• Last Update Posted: Feb 3, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

Participant Flow

Recruitment Details	One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.

Arm/Group Title	Trilogy Ventilator First, Then Standard of Care Ventilator	Standard of Care Ventilator First, Then Trilogy Ventilator
Arm/Group Description	These participants used the Trilogy Ventilator first, then Standard of Care Ventilator	Theses participants used the Standard of Care Ventilator first and then Trilogy Ventilator.
Period Title: Overall Study
STARTED	4	2
COMPLETED	4	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants Consented
Arm/Group Description	All participants consented for the study.
Overall Participants	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.2 (6.4)
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 16.7%
More than one race	0 0%
Unknown or Not Reported	5 83.3%
Region of Enrollment (participants) [Number]
Canada	6 100%

Outcome Measures

1. Primary Outcome

Title	Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Description	Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Time Frame	After one hour of ventilator use

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trilogy Ventilator	Standard of Care
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator	Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
Measure Participants	6	6
Mean (Standard Deviation) [mEq/L]	37 (7.5)	33.3 (11.9)

2. Primary Outcome

Title	Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Description	Comparable level of gas exchange for SpO^2
Time Frame	After one hour of ventilator use

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trilogy Ventilator	Standard of Care
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilog ventilator	Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
Measure Participants	6	6
Mean (Standard Deviation) [mmHg]	94.6 (4.0)	97.0 (1.9)

3. Secondary Outcome

Title	Heart Rate
Description	heart rate as measured by beats per minute
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trilogy Ventilator	Standard of Care
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator	Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
Measure Participants	6	6
Mean (Standard Deviation) [bpm]	114.5 (26.4)	103.8 (18.1)

4. Secondary Outcome

Title	Minute Ventilation
Description	Minute ventilation
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

One data point not captured

Arm/Group Title	Trilogy Ventilator	Standard of Care
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator	Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
Measure Participants	5	6
Mean (Standard Deviation) [Lpm]	4.9 (2.25)	5.3 (3.2)

5. Secondary Outcome

Title	Tidal Volume
Description	Tidal Volume
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

One data point not captured for a participant

Arm/Group Title	Trilogy Ventilator	Standard of Care
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator	Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
Measure Participants	5	6
Mean (Standard Deviation) [mL/kg]	239 (221)	226 (209)

Adverse Events

Arm/Group Title	Trilogy Ventilator		Standard of Care Ventilator
Arm/Group Description	Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator		Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator
All Cause Mortality
	Trilogy Ventilator		Standard of Care Ventilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Trilogy Ventilator		Standard of Care Ventilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Trilogy Ventilator		Standard of Care Ventilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.