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

Acute Respiratory Distress Syndrome Clinical Trial

— SiVent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582957
• Other study ID #: 1512M81688
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: October 8, 2022

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: October 8, 2022
• Est. primary completion date: October 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Sigh breaths
Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University Medical Center Brackenridge	Austin	Texas
United States	University of Maryland Medical System Shock Trauma Center	Baltimore	Maryland
United States	UT Southwestern (Parkland)	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	UCSF Fresno Community Regional Medical Center	Fresno	California
United States	University of Texas Medical School, Houston	Houston	Texas
United States	University of Southern California (LA County)	Los Angeles	California
United States	Christiana Care Health System	Newark	Delaware
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	UC San Diego Medical Center	San Diego	California
United States	Medical College of Wisconsin	Wauwatosa	Wisconsin
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	United States Department of Defense, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free Days (VFDs)	Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.	28 days
Secondary	All-cause Mortality	All-cause 28 day mortality	28 days
Secondary	ICU-free Days	Number of ICU-free days to day 28 after enrollment	28 days
Secondary	Number of Participants With Complications of Treatment	Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.	28 days
Secondary	Discharge Status	Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice	28 days
Secondary	Number of Participants Requiring Oxygen Therapy at Discharge	Number of Participants newly requiring continuous oxygen therapy at discharge.	28 days