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Changes in Hemodynamic Values With Posture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557009
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Kane High, Milton S. Hershey Medical Center

Brief Summary:

The study is designed as a prospective observational study. Each participant will have their BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for routine patient monitoring. Measurements will be recorded on an hourly basis during the day and for as many days as possible if the required measurements are being made for clinical care.

Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of convenience sampling. Data will be analyzed using a test of equivalence on the initial measurements (test of equivalence between two means) and then over time (repeated measurements) with a linear mixed-effects model.


Condition or disease
Blood Pressure

Detailed Description:

Invasive monitoring is a common method used in intensive care units to measure cardiovascular status. These parameters include central venous pressure (CVP), pulmonary artery pressure (PAP) cardiac output (CO) and arterial blood pressure (BP). There is a general understanding that these parameters vary with the position of the patient with the expectation that, as the patient goes from supine to sitting, these parameters decrease to some extent due to decreased venous return to the heart. Furthermore, the extent to which a patient might be reclining in bed can vary greatly from just having the head slightly raised to being totally upright. Different policies exist with respect to patient position when these measurements are made. The policies vary from no specified position to placing them completely flat for making the measurement and then returning them to a more upright position, usually 30 or 45 degrees. Decisions are based upon the supine measurements despite no clear correlation to the patient's usual position. This study will investigate the correlation between position and these parameters.

Patients in the HVICU will be approached by a member of the research team and asked for their verbal approval to record measurements made by their nurse. After receiving verbal consent to record the measurements, a member of the study team will record BP. CVP, PAP and CO as measured by the patient's nurse. These measurements will be recorded with the patient lying on the bed with the back of the bed raised to 30o and with the patient supine when the back of the bed is at 0o. The transducers will be leveled with the anterior axillary by zeroing of the transducer. After each position change, the team member will ask the nurse to wait 5 minutes to allow stabilization of these parameters before measuring and recording the parameters at that position. These parameters will be recorded on an hourly basis using the day for as many days as the required measurements are being made for clinical care. Other patient information recorded will be date, ejection fraction, BMI, height, weight, age, and PEEP, if the patient is intubated.

Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of convenience sampling. The sample size was calculated based on the initial measurement of CVP where our preliminary data shows a mean difference 1.28±2.93 mmHg, and assuming that values with a difference < 3 are equivalent, with an α = 0.05 and a power of 90. The calculation was done at the following website: http://www.sealedenvelope.com/power/continuous-equivalence. Data will be analyzed using a test of equivalence on the initial measurements (test of equivalence between two means) and then over time (repeated measurements) with a linear mixed-effects model.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Hemodynamic Values With Posture
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. central venous pressure supine and with head of bed at 30 degrees [ Time Frame: 48 hours post-operatively ]

Secondary Outcome Measures :
  1. cardiac output supine [ Time Frame: 48 hours post-operatively ]
  2. cardiac output with head of bed at 30 degrees [ Time Frame: 48 hours post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Hershey Medical Center having CABG and aortic valve surgery
Criteria

Inclusion Criteria:

  1. Adult patients (18 to 85 years of age) in the HVICU
  2. Have indwelling CVP or PA catheter.

Exclusion Criteria:

  1. Patients who have just undergone mitral valve surgery
  2. Patients that have PEEP > 10cmH2O

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557009


Locations
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United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kane High, MD MS Hershey Medical Center
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Responsible Party: Kane High, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02557009    
Other Study ID Numbers: 044000EP
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Keywords provided by Kane High, Milton S. Hershey Medical Center:
Hemodynamics
Central Venous Pressure
Pulmonary Artery Pressure
Cardiac Output