Blood and Lymph Conditions

All Conditions

Lymphedema

Lymphatic Diseases

Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Bioelectric Impedance Analysis

Exercise

Photoplethysmography

Questionnaire Administration

The Ohio State Comprehensive Cancer Center

Shannon Hainline

Carlo M. Contreras, MD

Carlo M Contreras, MD

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.

PRIMARY OBJECTIVE:

I. Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest.

SECONDARY OBJECTIVES:

I. In participants with lymphedema, describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm.

II. Tolerability of the transcutaneous sensors during the participant data collection session.

III. Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema.

OUTLINE:

Participants undergo BI and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema

Will assess in the following groups: (1) Healthy dominant arm, (2) healthy recessive arm, (3) lymphedema normal arm and (4) lymphedema affected arm. A single continuous value will be developed from the amplitude over time for each participant, both at rest and during activity. These measurements will be summarized using descriptive statistics (means, standard deviations or medians and interquartile ranges).

Assess by the Lymph-Q questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables.

Assess by the Tolerability questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables.

Will examine receiver operator characteristics using data from groups 3 and 4. Sensitivity, specificity, and area under that curve will be calculated, however these will be considered preliminary.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Neoplasms

Digestive System Diseases

Symptoms and General Pathology

Colorectal Neoplasms

Crohn Disease

Polyps

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Rectal Diseases

Control group using a hemodynamic standard protocol

Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)

Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

Anne-Lise Fiant, MD

The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

Medico economic evaluation of photoplethysmography use will be assessed with a specific unit of measure, using cost of treatment.

Two independent experts defined the presence of complication using an a priori classification.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study	NCT06305884	Hematopoietic a... Lymphedema Malignant Solid...	Bioelectric Imp... Exercise Photoplethysmog... Questionnaire A...	18 Years - 90 Years	Ohio State University Comprehensive Cancer Center
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study	NCT06305884	Hematopoietic a... Lymphedema Malignant Solid...	Bioelectric Imp... Exercise Photoplethysmog... Questionnaire A...	18 Years - 90 Years	Ohio State University Comprehensive Cancer Center
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen

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