Burns
Conditions
Keywords
Burns
Brief summary
The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation. Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.
Detailed description
This is a prospective, randomized, controlled trial comparing HFPV to conventional ventilator modes in the support of burn patients with respiratory failure. Burn patients who develop the need for mechanical ventilation present a variety of challenges that call for innovative therapeutic options. Even in the absence of smoke inhalation injury,decreased chest wall compliance from full thickness burns as well as massive fluid requirements are just a few variables that make it difficult to achieve gas exchange goals when attempting to apply conventional lung protective strategies recommended by the ARDS Net investigators.
Interventions
DEVICEVentilation - High Frequency Percussive Ventilation
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
DEVICEVentilation - ARDSnet
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.
Exclusion criteria
* Anticipated extubation within 24 hours of screening * Patients who are pregnant Patients not expected to survive for more than 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days During the First 28 Days | 28 days | The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | during hospitalization | In-hospital death. |
| Ventilator Associated Pneumonia | 28 days | Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator. |
| Days Free From Nonpulmonary Organ Failure | 28 | days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days. |
| Barotrauma | 28 days | Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele \>2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis. |
| Ventilator Associated Tracheobronchitis (VATB) | checked daily | Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission |
| Need for Rescue Ventilator | 28 days | Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation. |
Countries
United States
Participant flow
Recruitment details
After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the LTV arm required rescue, which served as the trigger to close the study to further enrollment. Between April 2006 and May 2009, 387 patients were screened for eligibility. 155 patients met criteria of which 62 were randomized, 31 in each arm.
Participants by arm
| Arm | Count |
|---|---|
| High Frequency Intervention with high frequency percussive ventilation | 31 |
| Conventional Low-tidal volume ventilation | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Conventional | High Frequency | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 18 | 35 years STANDARD_DEVIATION 18 | 36 years STANDARD_DEVIATION 18 |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 31 | 0 / 31 |
| serious Total, serious adverse events | 10 / 31 | 16 / 31 |
Outcome results
Primary
Ventilator-free Days During the First 28 Days
The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency | Ventilator-free Days During the First 28 Days | 12 Days | Standard Deviation 9 |
| Conventional | Ventilator-free Days During the First 28 Days | 11 Days | Standard Deviation 9 |
Secondary
Barotrauma
Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele \>2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Frequency | Barotrauma | 0 Participants |
| Conventional | Barotrauma | 4 Participants |
Secondary
Days Free From Nonpulmonary Organ Failure
days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.
Time frame: 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency | Days Free From Nonpulmonary Organ Failure | 15 Days | Standard Deviation 11 |
| Conventional | Days Free From Nonpulmonary Organ Failure | 15 Days | Standard Deviation 10 |
Secondary
Death
In-hospital death.
Time frame: during hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Frequency | Death | 6 Participants |
| Conventional | Death | 6 Participants |
Secondary
Need for Rescue Ventilator
Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Frequency | Need for Rescue Ventilator | 2 Participants |
| Conventional | Need for Rescue Ventilator | 9 Participants |
Secondary
Ventilator Associated Pneumonia
Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Frequency | Ventilator Associated Pneumonia | 10 Participants |
| Conventional | Ventilator Associated Pneumonia | 16 Participants |
Secondary
Ventilator Associated Tracheobronchitis (VATB)
Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission
Time frame: checked daily
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Frequency | Ventilator Associated Tracheobronchitis (VATB) | 2 Participants |
| Conventional | Ventilator Associated Tracheobronchitis (VATB) | 0 Participants |