Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System

Zhejiang University

Status: Active, not recruiting

Conditions: Infant，newborn; Vital Signs; Sleep

Treatments: Device: Mindray ECG monitor; Device: aEEG; Other: Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.; Device: Non-contact heart rate and respiratory rate monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT06573203

2024-IEC-0024-P-01

Details and patient eligibility

About

In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.

Full description

The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns admitted to our hospital for the first time, with gestational age ≥28w;
• Expected hospital stay ≥5 days.

Exclusion criteria

• Apgar score ≤3 at 1 or 5 min after birth;
• Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

Non-contact heart rate and respiratory rate monitoring system

Experimental group

Description:

After admission, the non-contact mattress is placed under a normal mattress, and heart rate, respiratory rate, and sleep-related parameters can be collected through induction.

Treatment:

Other: Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.

Device: aEEG

Device: Mindray ECG monitor

Electrocardiogram monitor

Active Comparator group

Description:

Measuring vital signs

Treatment:

Device: Non-contact heart rate and respiratory rate monitoring system

Amplitude-integrated EEG

Active Comparator group

Description:

Sleep parameters were continuously measured by aEEG for 6 hours after admission.

Treatment:

Device: Non-contact heart rate and respiratory rate monitoring system

Neonatal Sleep-Wake Assessment Tool

Active Comparator group

Description:

It is suitable for all newborns to observe and evaluate the sleep phase, wake period and regularity, and guide the choice of care time. The scale includes four dimensions: eye movement, breathing rate, facial expression and muscle activity. The score range of each dimension is 0 \~ 2 points, and the score range is 0 \~ 8 points.

Treatment:

Device: Non-contact heart rate and respiratory rate monitoring system