Perioperative Blood Pressures and Chronic Hypertension

• ClinicalTrials.gov Identifier: NCT02136810
• Recruitment Status: Completed
• First Posted: May 13, 2014
• Results First Posted: December 14, 2018
• Last Update Posted: December 14, 2018
• Sponsor: Yale University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control.

Condition or disease
Hypertension

Detailed Description:

A convenience sample of presurgical patients seen in a preadmission testing clinic were enrolled and sent home with a home blood pressure monitor that stored up to 50 readings. Participants were asked to return the BP cuff on the day of their surgery.

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Association Between Home Blood Pressures and Clinic Blood Pressures in Patients Presenting for Surgery.
• Actual Study Start Date: November 9, 2015
• Actual Primary Completion Date: January 11, 2017
• Actual Study Completion Date: January 16, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Performance of Blood Pressure Referral Threshold [ Time Frame: Subjects followed for approximately 1 year ]
   The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure >135/85mmHg will be calculated.

Secondary Outcome Measures :

1. Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures. [ Time Frame: Approximately 60 days ]
   In secondary analyses, the agreement between patients' self-reported blood pressure control (binary outcome) and home blood pressure monitor-determined blood pressure status (binary outcome) will we assessed via Cohen's kappa and raw indices of agreement.
2. Preidentified Subgroups [ Time Frame: 1 year ]
   The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.
3. Patient Perspectives [ Time Frame: 60 days ]
   The possible association of self-reported availability of primary care (5 point LIKERT scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
4. Patient Adherence [ Time Frame: 60 days ]
   The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
5. Preidentified Subgroup Analysis [ Time Frame: 1 year ]
   The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory surgical patients >= 21 years of age presenting for preadmission testing to a tertiary care hospital and who demonstrate elevated clinic blood pressures greater than or equal to 130/85mmHg.

Criteria

Inclusion Criteria:

• Ambulatory patients >= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.

Exclusion Criteria:

• Inability or unwillingness to independently operate a home blood pressure monitor.

Contacts and Locations

Locations

United States, Connecticut

Yale-New Haven Hospital PreAdmission Testing Clinic

New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Robert Schonberger, MD/MHS; Yale University

More Information

Publications:

Schonberger RB, Dai F, Brandt CA, Burg MM. Balancing Model Performance and Simplicity to Predict Postoperative Primary Care Blood Pressure Elevation. Anesth Analg. 2015 Sep;121(3):632-641. doi: 10.1213/ANE.0000000000000860.

Schonberger RB, Burg MM, Holt N, Lukens CL, Dai F, Brandt C. The relationship between preoperative and primary care blood pressure among veterans presenting from home for surgery: is there evidence for anesthesiologist-initiated blood pressure referral? Anesth Analg. 2012 Jan;114(1):205-14. doi: 10.1213/ANE.0b013e318239c4c1. Epub 2011 Nov 10.

Schonberger RB. Ideal blood pressure management and our specialty. J Neurosurg Anesthesiol. 2014 Jul;26(3):270-1. doi: 10.1097/ANA.0000000000000012.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02136810
• Other Study ID Numbers: 1509016399; K23HL116641 ( U.S. NIH Grant/Contract )
• First Posted: May 13, 2014
• Results First Posted: December 14, 2018
• Last Update Posted: December 14, 2018
• Last Verified: November 2018

Keywords provided by Yale University:

Hypertension; Perioperative Care

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases