BRS and Outcomes in Cardiothoracic Surgery

Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery

The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Cognitive Dysfunction; Atrial Fibrillation

Detailed Description

The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS) correlates with major outcomes after cardiac and thoracic surgery, including acute and chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis, approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be measured prior to surgery as well as immediately postoperatively. Outcomes will include acute pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively. Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative telemetry, the electronic medical record, and ECG performed prior to discharge. Finally, cognitive function will be assess via Mini-Mental State examination administered preoperative and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will be tested with regression models adjusted for appropriate covariates. Significance threshold alpha will be adjusted for the number of statistical tests using the Bonferroni correction. Our hypothesis is that patients with impaired preoperative BRS will have an increased incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline after surgery.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting for cardiac and thoracic surgery at Duke University Hospital, a quaternary referral center

Description

Inclusion Criteria:

• >= 18 years of age
• Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery

Exclusion Criteria:

• Any preexisting pain condition (defined as pain of >=3 months duration prior to enrollment)
• Pain at the time of enrollment interview
• Need for preoperative analgesics
• Preexisting chronic or paroxysmal atrial fibrillation
• Preexisting atrial or ventricular arrhythmia
• Need for preoperative anti-arrhythmic medication
• History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual deficits
• Alcoholism (>2 drinks/day)
• Psychiatric illness (any clinical diagnosis requiring therapy)
• Drug abuse (any illicit drug use in the preceding 3 months before surgery)
• Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
• Severe pulmonary insufficiency (home oxygen)
• Renal failure (serum creatinine >2.0 mg/dL)
• Non-English speaking
• Unable to read
• Participants who score <24 on baseline Mini Mental State examination

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgical; No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative day (POD) 1 baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min
POD 2 baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min
6 month baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	6 months
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h	Median NRS pain score in the first 24h after surgery	24 hours
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h	Median NRS pain score in the second 24h after surgery	48 hours
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1	GBS survey on POD 1	15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2	GBS survey on POD 2	15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo	GBS survey at 6 month follow-up visit	6 months
Chronic pain as assessed by the change in Brief Pain Inventory score	Change from baseline to 6 months postoperatively	Baseline, 6 months
Hyperalgesia	Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up	6 months
Area of hyperalgesia or allodynia	Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up	6 months
Postoperative atrial fibrillation	Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively	6 weeks
Postoperative cognitive change	Change from baseline to 6 months in the Mini Mental Status Exam score	Baseline, 6 months
Baseline psychological distress	As assessed by the Brief Symptom Inventory-18	15 min
6 month psychological distress	As assessed by the Brief Symptom Inventory-18	6 months
Baseline frailty	As assessed by the Modified Frailty Index	10 min

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurocognitive Disorders; Arrhythmias, Cardiac; Cognition Disorders; Pain, Postoperative; Atrial Fibrillation; Cognitive Dysfunction
• Other Study ID Numbers: Pro00083136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No