An interventional study of Ventilation - High Frequency Percussive Ventilation and Ventilation - ARDSnet in Burns, sponsored by United States Army Institute of Surgical Research. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-21.
Sponsored by United States Army Institute of Surgical Research · Not applicable, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 62 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →United States Army Institute of Surgical Research is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
Device: Ventilation - High Frequency Percussive Ventilation
Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation
Device: Ventilation - ARDSnet
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
Also known as: High Frequency Percussive Ventilation, Volumetric Diffusive Respirator
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
Also known as: Lung Protective Ventilation, Low Tidal Volume Strategy, Conventional Mechanical Ventilation
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
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
Death
In-hospital death.
Time frame: during hospitalization
Ventilator Associated Pneumonia
Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: checked daily
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.
| Milestone | High Frequency | Conventional |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
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.
| Days | High Frequency | Conventional |
|---|---|---|
| Ventilator-free Days During the First 28 Days | 12 ± 9 | 11 ± 9 |
days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.
| Days | High Frequency | Conventional |
|---|---|---|
| Days Free From Nonpulmonary Organ Failure | 15 ± 11 | 15 ± 10 |
In-hospital death.
| Participants | High Frequency | Conventional |
|---|---|---|
| Death | 6 | 6 |
Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
| Participants | High Frequency | Conventional |
|---|---|---|
| Ventilator Associated Pneumonia | 10 | 16 |
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.
| Participants | High Frequency | Conventional |
|---|---|---|
| Need for Rescue Ventilator | 2 | 9 |
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.
| Participants | High Frequency | Conventional |
|---|---|---|
| Barotrauma | 0 | 4 |
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
| Participants | High Frequency | Conventional |
|---|---|---|
| Ventilator Associated Tracheobronchitis (VATB) | 2 | 0 |
Collected over 28 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Frequency | — | 10/31 (32.3%) | 2/31 (6.5%) |
| Conventional | — | 16/31 (51.6%) | 0/31 (0%) |
| Event | High Frequency | Conventional |
|---|---|---|
| Ventilator Associtated PneumoniaRespiratory, thoracic and mediastinal disorders | 10/31 | 16/31 |
| BarotraumaRespiratory, thoracic and mediastinal disorders | 0/31 | 4/31 |
| Event | High Frequency | Conventional |
|---|---|---|
| Ventilator Associated TracheobronchitisRespiratory, thoracic and mediastinal disorders | 2/31 | 0/31 |
| Age, Categorical(Participants) | High Frequency | Conventional | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 29 | 58 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | High Frequency | Conventional | Total |
|---|---|---|---|
| Mean | 35 ± 18 | 37 ± 18 | 36 ± 18 |
| Sex: Female, Male(Participants) | High Frequency | Conventional | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 27 | 26 | 53 |
| Region of Enrollment(participants) | High Frequency | Conventional | Total |
|---|---|---|---|
| United States | 31 | 31 | 62 |
This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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United States Army Institute of Surgical Research