Do Arterial Catheters Reduce the Risk of Major Perioperative Complications

NCT02453815 | Completed

• 1 other identifier: 15-008
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of post operative complications

  Medical record will be reviewed for number of post operative complications

  30 days

Study Arms (2)

arterial catheter

EXPERIMENTAL

If a patient is randomized by the web-based system before non-cardiac surgery to receive an arterial catheter at surgery, then the subject will be placed in the experimental arm of the study.

Procedure: non-cardiac surgery; Other: arterial catheter

no arterial catheter

PLACEBO COMPARATOR

If a patient is randomized by the web-based system before non-cardiac surgery to not receive an arterial catheter at the time of surgery, then the subject will be placed in the placebo comparator arm of the study.

Procedure: non-cardiac surgery

Interventions

non-cardiac surgery PROCEDURE

all surgical procedures except cardiac

arterial catheter; no arterial catheter

arterial catheter OTHER

arterial catheter

arterial catheter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status 2-4 patients
• inpatient non-cardiac surgery
• radial arterial catheter might or might not reasonably be used based on co-morbidity or type of surgery.

You may not qualify if:

• the attending anesthesiologist requires or refuses an arterial catheter
• already have an arterial catheter
• catheter is contraindicated
• end-stage renal disease
• abnormal Allen's test
• known radial arterial pathology

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Kurz, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: May 27, 2015
• Study Start: June 1, 2015
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)