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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Sigh breaths

• Registration Number: NCT02582957
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2016-04-01
• Primary Completion: 2022-10-08
• Study Completion: 2022-10-08
• Results First Submitted: 2023-10-29
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Results First Posted: 2024-06-06
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sigh breaths	Sigh breaths	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.

Primary Outcome Measures

Name	Time	Method
Ventilator-free Days (VFDs)	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complications of Treatment	28 days	Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.
Discharge Status	28 days	Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice
All-cause Mortality	28 days	All-cause 28 day mortality
ICU-free Days	28 days	Number of ICU-free days to day 28 after enrollment
Number of Participants Requiring Oxygen Therapy at Discharge	28 days	Number of Participants newly requiring continuous oxygen therapy at discharge.

Trial Locations

Locations (15)

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

University Medical Center Brackenridge; 🇺🇸 Austin, Texas, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

UCSF Fresno Community Regional Medical Center; 🇺🇸 Fresno, California, United States

University of Southern California (LA County); 🇺🇸 Los Angeles, California, United States

UC San Diego Medical Center; 🇺🇸 San Diego, California, United States

University of Maryland Medical System Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

UT Southwestern (Parkland); 🇺🇸 Dallas, Texas, United States

University of Texas Medical School, Houston; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Medical College of Wisconsin; 🇺🇸 Wauwatosa, Wisconsin, United States