Do Arterial Catheters Reduce the Risk of Major Perioperative Complications
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Even slight reduction in serious complications related to blood pressure management would
      easily justify the cost and relatively rare complications consequent to arterial catheter
      insertion. However, it seems unlikely that major outcomes will be improved by the presumably
      slight difference in hemodynamic control resulting continuous blood pressure measurement
      rather than measurements at 2-5-minute intervals. There is considerable variation in practice
      and no clear consensus whether arterial lines should be placed or not, especially in ASA 2
      patients undergoing major non-cardiac surgery or ASA-3 patients undergoing moderate to major
      non-cardiac surgery. Clearly, if there is no benefit to outcome, arterial lines, which are
      invasive and costly, should not be placed routinely. The investigators therefore propose to
      test the primary hypothesis that use of arterial catheters decreases the risk of a collapsed
      composite of in-hospital mortality, re-admissions, MINS, AKI, stroke, respiratory and wound
      healing and gastro-intestinal complications after non-cardiac surgery.

      Secondarily, the investigators propose to test the hypotheses that arterial catheter use: 1)
      decreases the duration of hospitalization; 2) increases blood gas, electrolyte, and
      coagulation testing; 3) increases induction-to-incision time; and, 4) increases cost-of-care
      (supplies,, blood tests, and induction-to-incision time).
    

Detailed description: 
      This study will be conducted at the Cleveland Clinic Main Campus with IRB approval and
      written consent from participating patients. The investigators will enroll consented ASA
      Physical Status 2-4 patients having inpatient non-cardiac surgery in whom a radial arterial
      catheter might or might not reasonably be used based on co-morbidity or type of surgery.
      However, it is most likely that the majority of patients will be ASA 3 patients. Currently
      (based on a recent data pull) approximately 44% of ASA 3 patients receive an arterial
      catheter for non-cardiac surgery. The investigators expect that this insertion rate will
      remain constant throughout the study.

      Aside from randomized assignment to arterial catheter use, no other aspect of anesthetic or
      perioperative management will be controlled.

      When attending anesthesiologists exclude otherwise qualifying patients from the study, the
      investigators will ask them to designate which factors influenced their decision. Potential
      reasons will include: 1) type of procedure; 2) co-morbidities; 3) expected hemodynamic
      instability or blood loss; 4) patient position; and, 5) need for blood sampling.

      Demographic data to be obtained includes height (cm), weight (kg), age (yr.), gender, ASA
      physical status, and self-declared ethnicity. If available the investigators will collect
      social history (tobacco and alcohol use), medical history (pulmonary disease, cardiovascular
      disease, neurologic disease, drug usage (including but not limited to: statins, ß blockers,
      oral hypoglycemic agents and/or insulin), NSAIDs, diabetes (and whether insulin-dependent or
      not), and previous glucose-tolerance test results, preoperative hemoglobin and hematocrit,
      BUN and creatinine, electrolytes, preoperative EKG, and hemoglobin A1c (HbA1c).

      Anesthetic data will include volatile anesthetic dose in MAC-hours, as well as total doses of
      propofol and other sedative hypnotics. Hemodynamic, respiratory parameters, BIS values (if
      available) and distal esophageal temperature will be recorded at 10 minute intervals
      intraoperatively. Blood loss will be estimated; urine output and fluid administration
      including allergenic blood will be recorded. Intraoperative use and total dose of vasoactive
      drugs as well as antibiotic administration will be recorded. The investigators will also
      record duration of anesthesia as well as time from induction of anesthesia to surgical
      incision. Similar data will be recorded for patients who potentially qualify but are excluded
      from randomization by the attending anesthesiologist.

      Serum troponin and creatinine will be determined on postoperative days 1, 2 and 3 while in
      hospital. Blood will be drawn in conjunction with routine laboratory tests. The surgical team
      will be notified when troponin values ≥0.03 ng/ml are identified.

      All other study data will be obtained from the medical record, including patient
      characteristics, type of surgery, perioperative blood transfusions, mean-arterial pressure,
      vasopressor use, number of blood gas and coagulation tests, and duration of hospitalization,
      postoperative complications as well as readmissions.
    

Intervention name(s): non-cardiac surgery; arterial catheter
Intervention type(s): Procedure; Other
Intervention description(s): all surgical procedures except cardiac; arterial catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention