Pressure Sensitive Mats for Patient Monitoring in the NICU

June 22, 2021 updated by: JoAnn Harrold, Children's Hospital of Eastern Ontario
This is a pilot study that provides the investigators with an opportunity to assess the application of PSM technology for patient monitoring in the NICU. This is a prospective, observational, cohort study.The investigators expect the duration of infant participation in this study to be 6 hours per single recording session with no follow-up required.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Procedures/Evaluations

  • The trial will be conducted at the CHEO NICU. The non-invasive patient monitoring equipment that has no direct contact with infant's skin, includes a pressure sensitive mat (PSM) from the LX100 series (XSensor Technology Corp. Calgary, Canada, XSensor.com) and a video camera.
  • The patient will be lying in an incubator, on an overhead warmer neonatal bed, or an open crib (whatever bed type they are currently being nursed in/on). The patient's nurse will place the PSM on the mattress and under the patient's bedsheet where it will have no contact whatsoever with the patient. The PSM placement under the infant will happen at a time when the infant would normally be handled/moved.

  • Data from the following four sources will be recorded simultaneously in each session:

    1. Contact pressure data from PSM
    2. Physiologic monitor data including blood oxygen saturation (SpO2), heart rate (HR), pulse rate (PR), respiratory rate (RR), and the alarms associated with each of these physiologic data streams. This data is collected from monitors that the patient has attached as part of their usual care.
    3. Video of the patient
    4. Event annotations collected by a bedside research assistant on a PC, laptop or tablet.
  • All data will be de-identified using unique study identifiers. The NICU research team will assign these study identifiers and keep this information on a Master Study List separate from all recorded data.
  • The PSM connects to an X3 Pro Sensor Pack that feeds into an X3 Pro Electronic Platform that is connected via USB to a laptop running the X3 Pro software. The X3 Pro software is used to record PSM data and video simultaneously. The PSM is powered from an approved AC power supply and is connected to the data acquisition computer via USB. The XSensor PSM system is already being used with adult patients, however, the electrical safety of our final configuration will also be established through independent inspection (see below). The pressure mat will be covered by one or more bedsheets at all times. The baby will not be permitted to come in contact with the mat to reduce the risk of electrical shock and airway obstruction.
  • Bench tests will be conducted by CHEO Clinical Engineering to confirm that leakage current measurements from the mat and the entire system will meet the limits published in Requirement EN60601. If any deficiencies are identified alternations to the system will then be completed prior to a special inspection by Canadian Standards Association (CSA). A special electro medical inspection will be arranged with CSA for the final configuration of PSM, laptop, and power supplies.
  • The video camera will be mounted on a tripod to capture patient movements, routine care, and clinical interventions if any. We will capture the entire body, the head being very important as this is where most interventions occur such as nasal gavage feeding, ventilator support and airway suctioning. Video analysis has shown to be particularly useful for estimating RR in neonates [39].
  • A bedside research assistant (RA) will manage all data recordings on a computer kept by the patient's bedside for up to 6 hours per recording session.
  • Physiologic data including the patient's heart rate (HR), respiratory rate (RR), oxygen saturation levels (SpO2) and pulse rate (PR) as well as corresponding alarms for each data stream shall be logged from the bedside Dräger patient monitor onto a computer.
  • The RA will simultaneously annotate all patient events including movements, routine care, and clinical interventions on an electronic device such as a PC, laptop, or tablet.
  • The RN who will respond to the alarms will be asked for their clinical opinion as to the veracity (artifact or clinically important) of the alarms and this opinion will be annotated by the RA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants in the NICU will be eligible if their parents speak English or French and can be approached for consent.

Description

Inclusion Criteria:

  • Infants in the NICU will be eligible if their parents speak English or French and can be approached for consent.

Exclusion Criteria:

  • Patients who are moribund, suspected of having a neuromuscular condition affecting their movement or who are receiving muscle relaxant medications will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Incubator + <1500 g
Infants currently in an incubator with a weight of less than 1500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Incubator + 1500 - 2500 g
Infants currently in an incubator with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Overhead warmer + <1500 g
Infants currently in an overhead warmer with a weight less than 1500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Overhead warmer + 1500 - 2500 g
Infants currently in an overhead warmer with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Overhead warmer + >2500 g
Infants currently in an overhead warmer with a weight over 2500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Crib + 1500 - 2500 g
Infants currently in a crib with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.
Crib + >2500 g
Infants currently in a crib with a weight over 2500 grams will be monitored while lying on a pressure sensitive mat.
Device: Pressure sensitive mat
Infant placed on pressure sensitive mat and has physiological parameters recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of information collected from pressure sensitive mat.
Time Frame: Six hours
This study will examine the potential for incorporating PSM and video data analysis as part of an integrated patient monitoring environment.
Six hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Eastern Ontario

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NSERC Collaborative Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JoAnn Harrold, MD, Children's Hospital of Eastern Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB#17/76X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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