A Single Center Study to Demonstrate the Safety & Performance of

Status Completed

Clinical Trial Summary

This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.

Clinical Trial Description

Assessment of vital signs is an essential part of any clinical assessment and is undertaken regularly on patients accessing healthcare services. The accuracy of these measurements is of vital importance as decisions regarding the urgency of medical review and subsequent management are often influenced by these measures. The measurement of vital signs as part of normal medical care requires a level of medical / nursing skill or patient training. Observations can be altered by stress or anxiety making the results less representative of the patient's clinical state. This is particularly recognised in the measurement of blood pressure but stress can also alter heart and respiratory rate. Regular community and/or home monitoring of vital signs is useful in older populations and those with long-term conditions; standard of care methods can be labour intensive for health care providers, leading to greater financial burdens for health services. Lifelight® First is software which allows non-invasive, non-contact measurement of these observations. It can be used on a tablet (e.g. Apple® iPad®) that possesses an integral camera. The use of computer technology is now commonplace in society so the general public are likely to be accepting of this as a non-threatening method of measurement, thus reducing the impact of anxiety on the results. Lifelight® First therefore has potential application within various areas of the health care system, it could also be useful in settings where direct access to health care is limited or as a part of a telemedicine service. This study has been designed to evaluate the safety and performance of Lifelight® First, an investigational medical device. The data will be used to support the CE marking of the Lifelight® First device. The study design has been based upon the guidance in ISO standards and also within published scientific literature. Ultimately the data points to be obtained and methodology will be required to follow this guidance in order to obtain the CE mark. ;

Study Design

Related Conditions & MeSH terms

Vital Signs

Clinical Trial Details

NCT number	NCT03998098
Study type	Observational
Source	Xim Limited
Contact
Status	Completed
Phase
Start date	April 29, 2019
Completion date	May 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05908045` - Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?
Enrolling by invitation	`NCT05975658` - WIReD: Wireless Interstage Remote Device Study
Completed	`NCT03143062` - The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
Completed	`NCT03179267` - Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED	N/A
Not yet recruiting	`NCT05023356` - Non-contact Vital Signs Monitoring in Anesthesia
Recruiting	`NCT05970614` - The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients	N/A
Completed	`NCT01448161` - A Machine Learning Approach to Continuous Vital Sign Data Analysis
Recruiting	`NCT05013411` - Rethinking Observations in Mental Health
Completed	`NCT04678050` - Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics	Phase 1
Not yet recruiting	`NCT04976907` - Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement
Completed	`NCT01157832` - Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System	N/A
Completed	`NCT04003662` - Vital Sign Comparison Between Lifelight and Standard of Care - Development
Recruiting	`NCT05241483` - Remote Patient Monitoring and Detection of Possible Diseases With Artificial Intelligence Telemedicine System
Not yet recruiting	`NCT04627766` - Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch	N/A
Completed	`NCT04997694` - Effect of Preoperative Active Warming and Passive Warming Methods on Perioperative Hypothermia	N/A
Active, not recruiting	`NCT04935190` - Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
Completed	`NCT04935723` - The Effects of Reiki on Abdominal Surgery Patients' Anxiety, Fear, Postoperative Pain and Life Findings	N/A
Not yet recruiting	`NCT06427564` - Vital Signs Collection Via "Comestai" App
Completed	`NCT05131620` - Virtual Reality and Acupressure Applications; Effect on Pain, Anxiety, Vital Signs and Comfort	N/A
Completed	`NCT02524470` - Vital Signs Patch Early Feasibility and Usability Study v1.0	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms