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OpenTrials
Completed

NCT Number: NCT01896206

CNAP Accuracy in the Bariatric Surgery Population

This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).

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Key information

Conditions

Bariatric Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
  • Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Exclusion criteria

  • Patients with history of a peripheral neurologic or neuropathic disorder
  • Patients in whom an invasive arterial cannula cannot be placed
  • Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
  • Edematous patients

Treatment and study plan

CNAP monitor

Device

Patients undergoing bariatric surgery and being monitored using the CNAP monitor.

Primary outcomes

  1. The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.

    Time frame: Participants will be followed for the duration of surgery, an expected average of 2 hours.

    To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
Feb 27, 2015

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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