Respiratory Failure, Respiratory Insufficiency
Conditions
Keywords
noninvasive ventilation
Brief summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
Detailed description
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
Interventions
DEVICEUse of the V60 Mask Ventilator
The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
Sponsors
Respironics, California, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 7 years and \< 18 years * Weight \> 20 kg (44 lbs) * Respiratory failure or respiratory insufficiency * Ability to cooperate with the investigators * Designated adult able to provide Informed Consent
Exclusion criteria
* An endotracheal tube or tracheostomy in place * Hemodynamically instability * Prolonged apnea * Inability to maintain the airway * A recent history of cardiac and or respiratory arrest * Acute hemorrhage * Multiple organ system failure * Undrained pneumothorax * High risk for aspiration * Metastatic or terminal cancer * Do-not-resuscitate orders * Inability to clear respiratory secretions * Inability to fit a mask * Facial surgery, trauma, or deformity * Upper gastrointestinal or airway surgery * Pregnancy * Refractory delirium * PaO2 \< 50 mmHg on present settings * Designee unable or unwilling to provide Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Comfort | 30 minutes | Comfort on visual analog scale 0 - 100, 0 is best |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saturation of Arterial Oxygen | 30 minutes | — |
| Respiratory Rate | 30 minutes | Breathing rate in breaths per minute |
| Minute Ventilation | 30 minutes | Liters per minute that the patient breathes |
| Heart Rate | 30 minutes | Beats per minute that the patient's heart is beating |
| Blood Pressure | 30 minutes | Systolic and diastolic blood pressure |
Countries
Canada
Participant flow
Recruitment details
Hospitalized adult patients enrolled between Jan 17 and Mar 3, 2009.
Pre-assignment details
Excluded if did not meet inclusion or did meet exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| V60 First Experimental Study device (used as the experimental device) first in the cross-over study | 1 |
| Conventional First Experimental Study device (used as the experimental device) second in the cross-over study | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Conventional First | V60 First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 11.5 years STANDARD_DEVIATION 4.9 | 16.0 years STANDARD_DEVIATION 0 | 13.0 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment Canada | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / — | 0 / — |
| serious Total, serious adverse events | 0 / — | 0 / — |
Outcome results
Primary
Breathing Comfort
Comfort on visual analog scale 0 - 100, 0 is best
Time frame: 30 minutes
Population: Analysis was per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V60 First | Breathing Comfort | V60 | 10 visual analog scale | Standard Error 0 |
| V60 First | Breathing Comfort | Conventional | 33.3 visual analog scale | Standard Error 0 |
| Conventional First | Breathing Comfort | V60 | 40 visual analog scale | Standard Error 14.1 |
| Conventional First | Breathing Comfort | Conventional | 45 visual analog scale | Standard Error 7.1 |
Secondary
Blood Pressure
Systolic and diastolic blood pressure
Time frame: 30 minutes
Secondary
Heart Rate
Beats per minute that the patient's heart is beating
Time frame: 30 minutes
Secondary
Minute Ventilation
Liters per minute that the patient breathes
Time frame: 30 minutes
Secondary
Respiratory Rate
Breathing rate in breaths per minute
Time frame: 30 minutes
Secondary
Saturation of Arterial Oxygen
Time frame: 30 minutes