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Completed

NCT Number: NCT03640429

Accuracy of Non-invasive Blood Pressure Monitoring at the Wrist in Obese Patients

Arterial blood pressure (ABP) monitoring is a corner stone in perioperative management. However, proper control of SBP requires accurate measurement of ABP.

The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

Arterial blood pressure (ABP) monitoring is a corner stone in perioperative management. Recently, tight intraoperative individualized control of systolic blood pressure (SBP) (within 10% of baseline reading) was reported to reduce the risk of postoperative organ dysfunction in high risk patients undergoing abdominal procedures. However, proper control of SBP requires accurate measurement of ABP.

The gold standard for ABP measurement is through a catheter placed in an artery. Being an invasive, measurement of BP through an arterial catheter is restricted to patients with rapid major fluid shifts. Many indirect methods are used for measurement of ABP. Oscillometric blood pressure (OBP) monitoring is considered the standard non-invasive monitor for use in most clinical situations. In OBP monitor, a pressure transducer located in the cuff senses the series of small oscillations heart-beat induced pulse volume changes. These oscillations are detected during deflation of the cuff pressure from above the SBP to diastolic blood pressure (DBP).

The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. In obese patients, OBP monitoring is considered superior to auscultatory method which is limited by faint auscultatory sounds. However, application of blood pressure cuff at the upper arm in this population is frequently limited by large arm circumference and asymmetrical arm contour. Thus, locating the cuff at the wrist might be a more feasible alternative for the upper arm. OBP monitoring at the wrist was previously compared to auscultatory measurement of ABP in non-surgical patients. A recent study investigated the accuracy of OBP at the upper forearm in obese patients. No data to the best of our knowledge validated OBP monitoring at the lower forearm in obese patients using invasive blood pressure monitor as a reference standard.

The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged above 18 years)
  • obese (with body mass index above 30 Kg/squared meter)

Exclusion criteria

  • Peripheral vascular diseases
  • Upper limb operations
  • Upper limb scars
  • Upper limb deep venous thrombosis
  • Arrhythmias

Treatment and study plan

non-invasive blood pressure monitor

Device

non-invasive oscillometric blood pressure monitor will be applied at the arm, forearm, and at the wrist.

invasive blood pressure monitor

Device

invasive blood pressure monitor will be connected to a cannula inserted at the radial artery.

Primary outcomes

  1. Systolic blood pressure

    Time frame: 3 hours

    Systolic blood pressure measured in mmHg

Secondary outcomes

  1. Diastolic blood pressure

    Time frame: 3 hours

    Systolic blood pressure measured in mmHg

  2. mean blood pressure

    Time frame: 3 hours

    Mean blood pressure measured in mmHg

  3. Heart rate

    Time frame: 3 hours

    The number of heart beats per minute

  4. Body mass index

    Time frame: 5 minutes

    The ratio between the body weight and height of the patient measured by Kg per squared meter

  5. Arm circumference

    Time frame: 5 minutes

    The circumference of the arm measured in cm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Accuracy and Trending of Non-invasive Oscillometric Blood Pressure Monitoring at the Wrist in Obese Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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