Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care

NCT02950649 | Terminated FDA Device

• 1 other identifier: 5160227
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 3

Brief Summary

This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.

Conditions

Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy of subjective assessment compared to device assessment of cardiac index

  Comparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment

  Up to one year from date of randomization

Study Arms (2)

Hemodynamic Monitored Guided Assesment

This group will have the non-invasive hemodynamic monitoring device placed and the data will be used for comparison with routine subjective preoperative assessment assessment.

Device: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences

No Hemodynamic Monitored Guided Assesment

This group will have subjective assessment by the provider and this data will be compared to the device assessment of cardiac index..

Device: No Hemodynamic Monitored Guided Assesment

Interventions

invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences DEVICE

Experimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental).

Hemodynamic Monitored Guided Assesment

No Hemodynamic Monitored Guided Assesment DEVICE

Arm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions.

No Hemodynamic Monitored Guided Assesment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects with ASA classification level 3 and 4, with less than 5 metabolic events

You may qualify if:

• Adult patients (greater than 18 years of age)
• ASA classification 3 and 4 level patients with poor functional status,
• less than 5 metabolic equivalents (METs) -

You may not qualify if:

• \< 18 years of age, pregnancy,
• known severe peripheral artery disease,
• poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
• history of Raynaud's,
• refusal to provide written consent

Sponsors & Collaborators

• Loma Linda University: lead
• Edwards Lifesciences: collaborator

Study Sites (3)

Loma Linda Health

Loma Linda, California, 92354, United States

Location

Loma Linda University Department of Anesthesiology

Loma Linda, California, 92354, United States

Location

Pat Moore

Loma Linda, California, 92354, United States

Location

Study Officials

• Davinder Ramsingh, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Cardiothoracic Anesthesiology

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: November 1, 2016
• Study Start: November 17, 2016
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)