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Do Arterial Catheters Reduce the Risk of Major Perioperative Complications

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-cardiac surgery
arterial catheter
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

arterial catheter

no arterial catheter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of post operative complications
Medical record will be reviewed for number of post operative complications

Secondary Outcome Measures

Full Information

First Posted
February 12, 2015
Last Updated
January 24, 2020
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02453815
Brief Title
Do Arterial Catheters Reduce the Risk of Major Perioperative Complications
Official Title
Do Arterial Catheters Reduce the Risk of Major Perioperative Complications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
January 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arterial catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
no arterial catheter
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
non-cardiac surgery
Intervention Description
all surgical procedures except cardiac
Intervention Type
Other
Intervention Name(s)
arterial catheter
Intervention Description
arterial catheter
Primary Outcome Measure Information:
Title
Number of post operative complications
Description
Medical record will be reviewed for number of post operative complications
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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Do Arterial Catheters Reduce the Risk of Major Perioperative Complications

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