Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
- Conditions
- SleepInfant，newbornVital Signs
- Registration Number
- NCT06573203
- Lead Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Newborns admitted to our hospital for the first time, with gestational age ≥28w;
- Expected hospital stay ≥5 days.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sleep-wake state 10minutes after the meal, 5minutes each time, two times in total Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Proportion of quiet sleep The hospital stay lasted 6 hours non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated.
Proportion of active sleep The hospital stay lasted 6 hours non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated.
Number of sleep cycles The hospital stay lasted 6 hours The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
- Secondary Outcome Measures
Name Time Method Respiratory rate The hospital stay lasted 6 hours Respiratory rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average respiratory rate was calculated.
Heart rate The hospital stay lasted 6 hours Heart rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average heart rate was calculated.
Trial Locations
- Locations (1)
The Children's Hospital Affiliated to the Medical College of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The Children's Hospital Affiliated to the Medical College of Zhejiang University🇨🇳Hangzhou, Zhejiang, China