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

NCT03998098 | Completed

• 1 other identifier: X4
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vital Signs

Keywords

Blood Pressure; SPO2; Oxygen Saturation; Respiratory Rate; Pulse; Breathing Rate; Heart Rate

Outcome Measures

Primary Outcomes (4)

• Blood Pressure Readings Validation

  Agreement of Lifelight® First standard of care and range for blood pressure as per ISO 81060-2-Non-invasive-sphygmomanometers-Part 2-Clinical validation of automated measurement type

  Single Visit; up to one day

• Oxygen Saturation Readings Validation

  Agreement of Lifelight® First standard of care and range for oxygen saturation as per ISO 80601-2-61-Medical electrical equipment-Part 2-61:Particular requirements for basic safety and essential performance of pulse oximeter equipment

  Single Visit; up to one day

• Heart Rate (pulse) Readings Validation

  Agreement of Lifelight® First standard of care and range for heart rate (pulse) function as per ISO 80601-2-61- Particular requirements for basic safety and essential performance of pulse oximeter equipment

  Single Visit; up to one day

• Respiratory Rate Readings Validation

  Agreement of Lifelight® First standard of care and range for respiratory rate by manually counting chest rises.

  Single Visit; up to one day

Study Arms (4)

Oxygen Saturation (Oximetry)

Arm to determine the performance of the Oxygen Saturation measurement in LifeLight First

Diagnostic Test: Oxygen Saturation (Oximetry)

Heart Rate (Pulse)

Arm to determine the performance of the Heart Rate measurement in LifeLight First

Diagnostic Test: Heart Rate (Pulse)

Respiratory Rate

Arm to determine the performance of the Respiratory Rate measurement in LifeLight First

Diagnostic Test: Respiratory Rate

Blood Pressure

Arm to determine the performance of the Blood Pressure measurement in LifeLight First

Diagnostic Test: Blood Pressure

Interventions

Oxygen Saturation (Oximetry) DIAGNOSTIC_TEST

Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers

Also known as: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First

Oxygen Saturation (Oximetry)

Heart Rate (Pulse) DIAGNOSTIC_TEST

Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers

Also known as: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First

Heart Rate (Pulse)

Respiratory Rate DIAGNOSTIC_TEST

Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers

Also known as: Two Clinical Observers, LifeLight First

Respiratory Rate

Blood Pressure DIAGNOSTIC_TEST

Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers For participants only participating in the Blood Pressure Arm of the trial, they will not be required to enter the normobaric chamber but will have their blood pressure readings taken in the ambient environment including lying supine in order to generate hypotensive readings.

Also known as: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First

Blood Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion/exclusion criteria is limited to the intended use of the device, therefore only individuals, of any sex, over the age of 18 will be included in the study. The individuals for the purpose of the study have to be able to perform physical activity in the form of the ergometer if they are undertaking the exercise component.

You may qualify if:

• Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
• Subject is ≥18 years of age
• Subject's health status: individual is considered to be healthy (hypertension and hypotension is permissible. Other stable diseases at the time of testing are also permissible)
• Subject is capable of undergoing controlled hypoxaemia to the levels called for the in the protocol with minimal medical risk (unless only participating in the blood pressure study).

You may not qualify if:

• Subject cannot expose their face fully for a reading to be taken
• Subject is unable to give informed consent
• Subject is outside of the specified age range
• Subject has already taken part in the study (all 4 sub studies)
• Subject with significant irregular heart rhythm or any disease that might affect the results of the study
• Subject is not capable of undergoing controlled hypoxia and would be placed at undue medical risk if this occurred
• Subject has any contraindications identified that would deem them unsuitable to take part

Sponsors & Collaborators

• Xim Limited: lead
• University of Portsmouth: collaborator

Study Sites (1)

University of Portsmouth, Department of Sport and Exercise Science

Portsmouth, England, PO1 2HY, United Kingdom

Location

MeSH Terms

Interventions

Oxygen Saturation; Oximetry; Heart Rate; Pulse; Respiratory Rate; Blood Pressure

Intervention Hierarchy (Ancestors)

Metabolism; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiration; Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 25, 2019
• Study Start: April 29, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

GB (1)