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

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"The study team wants to know if adding a sigh-type of breath to a ventilator reduces chances of developing more serious lung problems."
Age: 18 to 89 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Acute Respiratory Distress Syndrome
Type: Other study
Target:
304 Participants
Investigator:
Description
When patients have breathing problems, some may need support from a machine that helps them breathe. This machine is called a mechanical ventilator. Most of the time the machine works by delivering the same amount of air each time the patient takes, or is given, a breath.

This study plans to examine adding large breaths, like you take when you sigh or yawn. These will be given at a rate that is like the rate people normally sigh. The study team wants to know if adding this type of breath will reduce the chance of you developing more serious lung problems.
This study requires

Participating in the study will require no additional tests or procedures other than what is part of your standard medical care.

You will be put into one of two groups of patients. The choice of which group you will be in will be decided completely by chance (for example, by flipping a coin). Both groups of patients will receive the type of care their doctor believes is necessary. If you are assigned to the first group of patients, your doctor will adjust the breathing machine the way your doctor believes it should be set.

If you are in the second group of patients, your doctor will adjust the breathing machine the way your doctor believes it should be set. Also, the machine will be set to deliver one large breath (a sigh) every six minutes.

You will receive your assigned study treatment any time you need a breathing machine during the 28 day study period.

Who can participate

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:

  1. Traumatic brain injury

  2. 1 long bone fractures

  3. Shock on arrival in the Emergency Department (systolic BP < 90 mmHg)

  4. Lung contusion

  5. Receipt of > 6 units of blood

Exclusion Criteria:

  1. Inability to obtain consent from the patient or his/her legally authorized representative (LAR)

  2. Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention

  3. Age limitations per Institutional Review Board regulations

  4. 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

  5. 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

  6. Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations

  7. Prisoners, per Human Subjects regulations

  8. 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

  9. 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

  10. Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints

  11. 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.

  12. 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).

  13. Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).

Benefits and risks of participating
BENEFITS:

We can promise no benefits to you from participating in this research.


RISKS:

Your physician will review all the risks of this study with you.
Compensation
You will not be paid for taking part in this study.
Resources
Schedule
Study duration and period
You will be in the study for about 28 days.
Recruitment period
From Jan. 13, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Chancey Sweeney
Research Topic
Conditions:
  • Acute Respiratory Distress Syndrome

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