Postoperative ComplicationsNCT02453815
Do Arterial Catheters Reduce the Risk of Major Perioperative Complications
A study testing non-cardiac surgery and arterial catheter in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- non-cardiac surgery and arterial catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- non-cardiac surgery, arterial catheter
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-cardiac surgeryProcedure or surgery
all surgical procedures except cardiac
arterial catheterOther
arterial catheter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of post operative complications
Medical record will be reviewed for number of post operative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Kurz, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453815
- Sponsor's protocol ID
- 15-008
- Status last verified
- Jan 2020
- First submitted
- 12 Feb 2015
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Arterial Catheters Reduce the Risk of Major Perioperative Complications
- ClinicalTrials.gov ID
- NCT02453815
- Acronym / sponsor ID
- 15-008
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arterial catheter | Experimental | Procedure: non-cardiac surgery, Other: arterial catheterIf 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. |
| no arterial catheter | Placebo comparator | Procedure: non-cardiac surgeryIf 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-cardiac surgeryall surgical procedures except cardiac | Procedure or surgery | arterial catheter, no arterial catheter |
| arterial catheterarterial catheter | Other | arterial catheter |
Primary outcome
Number of post operative complications
Time frame: 30 days
Medical record will be reviewed for number of post operative complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kurz, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-cardiac surgery and arterial catheter in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of post operative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.