Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04144166
Other study ID # CS-011-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 29, 2019
Est. completion date December 23, 2019

Study information

Verified date January 2021
Source Nihon Kohden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.


Description:

A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion. The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 23, 2019
Est. primary completion date December 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Individuals 18 years of age or older 2. Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH) Exclusion Criteria: 1. Pregnant 2. Prisoners 3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor 4. Patients' deemed clinically unstable by the clinical team

Study Design


Related Conditions & MeSH terms


Intervention

Device:
capillary refill index (CRI)
a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Locations

Country Name City State
United States North Shore University Hospital Manhasset New York

Sponsors (1)

Lead Sponsor Collaborator
Nihon Kohden

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive Capability of the Altered Peripheral Perfusion The area under the curve (AUC) of the receiver operator characteristic (ROC) curve analysis on CRI values to predict probability of altered peripheral perfusion determined with the CRT test. < 30 min *right after enrollment
Secondary Correlation of Device CRI to Conventional (Visual) CRT Spearman's correlation coefficient to assess the correlation between CRI and CRT values. < 30 min *right after enrollment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03281707 - NIRS and DO2i Correlation N/A
Completed NCT03001531 - Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia N/A
Recruiting NCT05492968 - The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance Phase 4
Completed NCT04081974 - Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.
Recruiting NCT03747731 - A Non-invasive Evaluation of Kidney-Lung Interactions
Recruiting NCT06254833 - Microdosing ICG for Serial Colonic Perfusion Study During Surgery N/A
Completed NCT03860493 - Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device
Completed NCT03711916 - Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery N/A
Not yet recruiting NCT06077396 - Does Radial Artery Cannulation Affect the Perfusion Index(PI) of the Hand in Liver Transplant Operations? N/A
Not yet recruiting NCT04907071 - Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection N/A
Recruiting NCT04424069 - OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes N/A
Recruiting NCT05276167 - Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma N/A
Terminated NCT03715270 - Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
Terminated NCT03716050 - The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems Phase 2/Phase 3
Recruiting NCT06019546 - PErfusion QUality ODds
Recruiting NCT04929873 - Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology N/A
Recruiting NCT06047158 - Effects of Omega-3 Fish Oil Fat Emulsion on Rehabilitation and Immune Function After Radical Surgery Combined With Intraperitoneal Hyperthermic Infusion Chemotherapy in Patients With Locally Advanced Gastric Cancer
Active, not recruiting NCT05517044 - The Pre-acclimatization Augmented Extreme Altitude Expedition N/A
Terminated NCT03843307 - Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study N/A
Completed NCT06405282 - Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction