Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.

Detailed Description
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Patients in intensive care units (ICUs) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation will be randomized to either usual care or usual care with the addition of sigh breaths given once every 6 minutes. Patients will be randomized to one of the two study arms as soon as possible, but not longer than 24 hours after initiation of invasive mechanical ventilation. Patients will be followed for 28 days to assess ventilator-free days (VFDs), mortality, ICU-free days, and the occurrence of complications.

Official Title
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Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Other: Sigh breaths


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in an intensive care unit (ICU) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation who also have one or more of the following: Traumatic brain injury > 1 long bone fractures Shock on arrival in the Emergency Department (systolic BP < 90 mmHg) Lung contusion Receipt of > 6 units of blood Exclusion Criteria: Inability to obtain consent from the patient or his/her legally authorized representative (LAR) Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention Age limitations per Institutional Review Board regulations Undergoing invasive mechanical ventilation for > 24 hours, excluding any time during which the patient was being ventilated in the operating room, CT or IR, as this could represent too long a delay in instituting the intervention for it to have a chance of being effective Presence of malignancy or other irreversible disease or condition for which the six month mortality is estimated to exceed 50% (e.g., chronic liver disease with a Child-Pugh Score of 10-15, malignancy refractory to treatment) as this could affect the clinical course and cloud interpretation of the endpoints Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations Prisoners, per Human Subjects regulations Neurological condition that could impair spontaneous ventilation (e.g., C5 or higher spinal cord injury as this could affect the clinical course and cloud interpretation of the ventilator-free day endpoint Lack of availability of Dräger Evita Infinity V500 ventilator as this is the only ventilator capable of delivering sigh breaths as described in the protocol Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints Treating physicians being unwilling to use low VT ventilation strategy when ARDS is diagnosed as low VT ventilation is now considered standard of care for patients with ARDS. Moribund, not expected to survive 24 hours as this could affect the clinical course and cloud interpretation of the endpoints13. Treating physician's decision to use airway pressure release ventilation (APRV). Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sigh breaths<br>Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs > 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. | Other: Sigh breaths<br>* Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.<br>|
| No Intervention: Usual Care<br>Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days (VFDs) | The difference between 28 and the day the patient was removed from any form of mechanical ventilation (i.e., invasive, non-invasive, continuous or intermittent). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause 28 day mortality | 28 days | 
| ICU-free days | Number of ICU-free days to day 28 after enrollment | 28 days | 
| The occurrence of complications of treatment | Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele. | 28 days | 
| Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice | Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice | 28 days | 
| Newly requiring continuous oxygen therapy at discharge | Newly requiring continuous oxygen therapy at discharge | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, Shock Lung, Acute Chest Syndrome, Respiratory Distress Syndrome, Adult, Respiratory insufficiency, Trauma