MedTrace Logo

Do Arterial Catheters Reduce the Risk of Major Perioperative Complications

NCT02453815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2020-01-28

No results posted yet for this study

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).

Conditions

  • Postoperative Complications

Interventions

PROCEDURE

non-cardiac surgery

all surgical procedures except cardiac

OTHER

arterial catheter

arterial catheter

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Andrea Kurz, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-01-24
Completion
2020-01-24

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453815 on ClinicalTrials.gov