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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Frequency | Experimental | Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation |
|
| Conventional | Active Comparator | Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilation - High Frequency Percussive Ventilation | Device | Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days Free From Nonpulmonary Organ Failure | days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days. | 28 |
| Death | In-hospital death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin K Chung, MD | United States Army Insitute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15753734 | Background | Salim A, Martin M. High-frequency percussive ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S241-5. doi: 10.1097/01.ccm.0000155921.32083.ce. | |
| 10793162 | Background | Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Frequency | Intervention with high frequency percussive ventilation |
| FG001 | Conventional | Low-tidal volume ventilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Frequency | Intervention with high frequency percussive ventilation |
| BG001 | Conventional | Low-tidal volume ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Days | 28 days |
|
28 days
Ventilator Associated Pneumonia
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Frequency | Intervention with high frequency percussive ventilation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Barotrauma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventilator Associated Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Defined as carinal or mainstem airway friability and sloughing with associated bleeding. |
After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the Conventional arm required rescue, which served as the trigger to close the study to further enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | USAISR | 210-916-3054 | kevin.chung@us.army.mil |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| Ventilation - ARDSnet | Device | Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL) |
|
|
| during hospitalization |
| Ventilator Associated Pneumonia | Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator. | 28 days |
| 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. | 28 days |
| 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. | 28 days |
| 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 | checked daily |
| 20639746 | Derived | Chung KK, Wolf SE, Renz EM, Allan PF, Aden JK, Merrill GA, Shelhamer MC, King BT, White CE, Bell DG, Schwacha MG, Wanek SM, Wade CE, Holcomb JB, Blackbourne LH, Cancio LC. High-frequency percussive ventilation and low tidal volume ventilation in burns: a randomized controlled trial. Crit Care Med. 2010 Oct;38(10):1970-7. doi: 10.1097/CCM.0b013e3181eb9d0b. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| 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. | Posted | Mean | Standard Deviation | Days | 28 |
|
|
|
| Secondary | Death | In-hospital death. | Posted | Number | Participants | during hospitalization |
|
|
|
| Secondary | Ventilator Associated Pneumonia | Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator. | Posted | Number | Participants | 28 days |
|
|
|
| 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. | Posted | Number | Participants | 28 days |
|
|
|
| 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. | Posted | Number | Participants | 28 days |
|
|
|
| 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 | Posted | Number | Participants | checked daily |
|
|
|
| 10 |
| 31 |
| 2 |
| 31 |
| EG001 | Conventional | Low-tidal volume ventilation | 16 | 31 | 0 | 31 |
|
| Ventilator Associtated Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | VAP as defined by the American Thoracic Society and the Infectious Disease Society of America |
|
|
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