An interventional study of Low tidal volume ventilation and Airway pressure release ventilation in Acute Respiratory Distress Syndrome, sponsored by Saskatchewan Health Authority - Regina Area. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Saskatchewan Health Authority - Regina Area · Not applicable, Interventional, and Treatment
This study will examine the feasibility of a large clinical trial investigating the effectiveness of airway pressure release ventilation and low tidal volume ventilation for patients with moderate-to-severe acute respiratory distress syndrome.
Acute respiratory distress syndrome (ARDS) is a disease that has an incidence of 5% of hospitalized mechanically ventilated patients. ARDS is associated with high morbidity and mortality in critically ill patients, with mortality reported as high as 45% in severe ARDS. Patients who develop ARDS will require mechanical ventilation. Patients with ARDS are graded by the partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) into three categories of severity: mild (PaO2/FiO2 201-300 mm Hg), moderate (PaO2/FiO2 101-200 mmHg), and severe (PaO2/FiO2 ≤ 100).
Volutrauma and barotrauma are thought to contribute to the development of ARDS and alter mortality. The damage that occurs to the lungs manifests itself as inflammation, which leads to poor gas exchange of oxygen and carbon dioxide. Several strategies of lung-protective mechanical ventilation have been investigated in ARDS, including the use of low tidal volume ventilation (LTVV) or ARDSNet strategy, high frequency oscillation ventilation (HFOV), and airway pressure release ventilation (APRV). Lung protective strategies may be best beneficial prior to the onset of the development of ARDS or early in the course of the disease. As a result of the ARDSNet trial, LTVV has been adopted as the usual standard of care of ventilation and safest mode of ventilation for patients with ARDS.
Recently, APRV has been proposed as a potential alternative to LTVV. APRV is a form of ventilation that keeps the lungs inflated through the majority of the breath cycle and allows patients to breathe spontaneously above this level of inflation. APRV allows for spontaneous respiration with increased airway pressure, potentially allowing for decreased sedation, shorter duration of mechanical ventilation, and decreased need for vasopressors. APRV has been associated with possible reduction in incidence of ARDS and in-hospital mortality in non-randomized observational studies. In patients with established ARDS, the use of APRV has also not been well studied, with most studies limited to small observational studies often with no comparison group. One randomized trial using APRV alone had less than 30% of patients having a diagnosis of ARDS and did not show any difference in any outcomes. Recently, Zhou and colleagues conducted a randomized trial comparing APRV to conventional ventilation in 138 mechanically ventilated patients with mild to severe ARDS and found that APRV may shorten the duration of mechanical ventilation and reduce intensive care unit (ICU) length of stay.
While some of these studies had shown promise of APRV compared to LTVV, there has not been acceptance of APRV into guidelines as first line ventilation, and recommendations of institutions such as the Canadian Agency for Drugs and Technology in Health (CADTH) recommends interpreting these results with caution. Consequently, there remains clinical equipoise on this issue. Some ICU clinicians will currently use APRV as a rescue mode of ventilation in ARDS in their clinical practice while others will continue with the use of LTVV. We would like to randomize patients to LTVV or APRV and examine the feasibility of conducting a large multicentre randomized controlled trial in Canada.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Saskatchewan Health Authority - Regina Area is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Severe chronic obstructive pulmonary disease as defined by either:
Conventional low tidal volume ventilation
Device: Low tidal volume ventilation
Early use of airway pressure release ventilation
Device: Airway pressure release ventilation
Conventional ventilation strategy for patient with ARDS
Experimental ventilation protocol for patients with ARDS
Informed consent rate
A successful informed consent rate will be defined as ≥70% of substitute decision makers or patients approached choosing to participate in this trial
Time frame: Informed consent rate will be measured over a 1 year period of the pilot study
Recruitment rate
A successful recruitment rate will be achieving at least 15 patients over the 1 year period.
Time frame: Recruitment rate will be measured over the one year of the pilot study.
Protocol adherence rate
An adherence rate of at least 80% will be considered successful.
Time frame: Protocol adherence will be measured for each study patient, and compiled over the duration of the pilot study (i.e. 1 year).
28-day mortality
Death, measured from time of enrollment until 28 days.
Time frame: Up to Day 28
In-hospital mortality
Death, at hospital discharge
Time frame: Up to 365 days
ICU length of stay
Length of stay in the intensive care unit
Time frame: Up to 365 days
Hospital length of stay
Length of stay in the hospital in days
Time frame: Up to 365 days
Length/duration of mechanical ventilation
Length of time patient was on mechanical ventilation
Time frame: Up to 365 days
Incidence of tracheostomy
Incidence of tracheostomy during their ICU stay
Time frame: Up to 365 days
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Saskatchewan Health Authority - Regina Area