A Phase 2 interventional study of Mechanical Ventilation in Respiratory Failure, Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS), sponsored by Intermountain Health Care, Inc.. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by Intermountain Health Care, Inc. · Phase 2, Interventional, and Treatment
APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.
This prospective un-blinded randomized trial will follow patients with respiratory failure and ALI/ARDS who require invasive mechanical ventilation in select ICUs. Patients will be allocated to respiratory support with either APRV mode or volume control (AC) mode of mechanical ventilation. Qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the ICU. Identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. Patients will remain on the assigned mode of ventilation until they are extubated and discharged from the ICU.
Procedures for treatment evaluation include daily monitoring of the Ventilator protocol in each arm. Clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. The previously published ARDS Network continuous positive airway pressure (CPAP) weaning protocol will be used for all patients enrolled.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's planned enrollment of 246 is above the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Intermountain Health Care, Inc. is the lead sponsor of 120 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.
Device: Mechanical Ventilation
Standard volume control ventilation with the ARDS Net protocol.
Device: Mechanical Ventilation
APRV Habashi protocol which sets Plow equal to 0.
Device: Mechanical Ventilation
Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
P/F Ratio on Day 3 of Mechanical Ventilation
Our first objective is to measure and compare the partial pressure of oxygen in the artery to the inspired oxygen ratio (P/F ratio) on day 3 of mechanical ventilation. We will also collect and compare common variables used to evaluate lung injury and severity of respiratory failure in both groups. These variables and markers include: the Oxygenation index (OI) and standard blood gas parameters (PH, PaCO2 and PaO2).
Time frame: Day 3
Amount/Duration of Sedative & Vasoactive Medication
Our second objective is to compare the amount and duration of sedative medication and vasoactive medication per patient per/day required in each group. Duration of vasoactive medications and sedation (# of days) and quantitative amounts per kilogram will be compared. Measurements will include Mean Arterial Blood Pressure (MAP), Central venous pressure (CVP), and daily fluid balance between patients on AC and APRV.
Time frame: Up to ICU discharge
Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.
Our third objective is to evaluate the feasibility of 2 previously developed APRV paper protocols (APRVa and APRVb) and document the clinician compliance with each paper APRV protocol. We will also track common events associated with mechanical ventilation. The incidence of pneumothorax defined as any ventilator-barotrauma resulting in chest tube placement, will be carefully followed.
Time frame: Up to ICU discharge
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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