Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Study Overview
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Brief Summary
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Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.

Detailed Description
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Patients in the medical intensive care unit (MICU) often receive arterial lines as standard of care, however there are little data to support this practice. Investigators will randomly assign consecutive weeks to either current practice(control) or to a more conservative practice of not placing invasive arterial lines except for limited indication indications as defined below (intervention). Patients entering during an intervention week will be treated according to the intervention practice throughout their ICU stay. Likewise, patients entering during a control week will be treated according to current standard practice. Permuted block randomization will be used to assure equal numbers of intervention and control weeks. All outcome measures will be obtained through EPIC data analytics and post-hospitalization phone calls. Weekly randomization codes will be generated by the study statisticians and delivered to MICU staff via sealed envelopes to be opened at the beginning of each week.

Official Title
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Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Conditions
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Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock, Hypotension, Bloodstream Infection, Vasopressor Adverse Reaction, Renal Failure

Intervention / Treatment
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* Other: Restricted-use of arterial catheter
* Other: Standard-use of arterial catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects admitted to the medical intensive care unit Exclusion Criteria: Clinical discretion of the attending physician Severe pulmonary hypertension (right ventricular systolic pressure > 60 mmHg) Unreliable pulse oximetry Unreliable non-invasive blood pressure monitoring Absolute need of arterial blood gas measurement after 5 consecutive failed arterial blood gas sticks Extracorporeal membrane oxygenation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restricted-use of arterial catheters<br> | Other: Restricted-use of arterial catheter<br>* The investigator will restrict the use of arterial catheters unless exclusion criteria is met.<br>|
| Active Comparator: Standard-use of arterial catheters<br> | Other: Standard-use of arterial catheter<br>* The investigator will allow standard-use of arterial catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days hospitalized in the medical intensive care unit (length-of-stay) | Number of days hospitalized in the medical intensive care unit | inpatient hospitalization (approximately 1 to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay) | Number of days hospitalized in a non- medical intensive care unit | inpatient hospitalization (approximately 1 to 30 days) | 
| Number of days using a mechanical ventilator (Ventilator-days) | Number of days spent on a mechanical ventilator | inpatient hospitalization (approximately 1 to 30 days) | 
| Number of days using vasopressor medicines (vasopressor-days) | Number of days using vasopressor medicines | inpatient hospitalization (approximately 1 to 30 days) | 
| Number of blood transfusions received during hospitalization (packed red blood cell transfusions) | Number of blood transfusions received during hospitalization | inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions | 
| Number of participants experiencing a bloodstream infection related to invasive arterial catheter use | Number of participants experiencing a bloodstream infection related to invasive arterial catheter use | inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections | 
| Number of participants experiencing a vascular injury related to the invasive arterial catheter | vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury | inpatient hospitalization (approximately 1 to 30 days) | 
| Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines (28-day mortality while on vasopressors) | Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines | Inpatient or outpatient death within 1 to 28 days | 
| Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality) | Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause | Inpatient or outpatient death within 1 to 28 days | 
| Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality) | The outcome of death that has occurred for subjects from all causes after 90 days | Inpatient or outpatient death within 1 to 90 days | 
| Number of patients experiencing renal failure while hospitalized | Renal failure is defined as any renal replacement therapy | inpatient hospitalization (approximately 1 to 30 days) |