Heart Rate MonitoringNCT06076057
Vital Signs Monitoring of Emergency Responders in Different States
An observational study of Heart Rate Monitoring, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are: Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Monitoring
- What is being tested?
- vital signs monitoring
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Frontline National Grid Emergency Responders
Who may be able to join
- No history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia.
- Voluntarily participated in this study and signed an informed consent form
Who cannot join
- Patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Li yang, 15688880756, ly974122@163.com
About this study
The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are:
- Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.
- Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.
Participants will normal operating conditions, the researcher collects vital sign information.
Read the detailed description
- General information: name, age, height, weight, place of origin, smoking history, and whether or not they snore.
- 10 vital signs and behavioral parameters in different states (quiet, after duty, after physical training), including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, partial pressure of transcutaneous carbon dioxide.
- 8 vital signs and behavioral parameters in different environments (overhead, confined space, energized work, work site), including: respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.
- Conditions
- Heart Rate Monitoring
- Being tested
- vital signs monitoring
- Keywords
- Vital Signs, Respiration, transcutaneous oxygenation, end-expiratory carbon dioxide
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital signs monitoringDiagnostic test
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
| Study group | Role | What they receive |
|---|---|---|
| 8:00 Measurement team | At 08:00 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. Receives: Diagnostic Test: vital signs monitoring | |
| 10:30 Measurement team | At 10:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. Receives: Diagnostic Test: vital signs monitoring | |
| 16:30 Measurement team | At 16:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. Receives: Diagnostic Test: vital signs monitoring | |
| high altitude environment | In high altitude environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration Receives: Diagnostic Test: vital signs monitoring | |
| limited space | In limited space environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration Receives: Diagnostic Test: vital signs monitoring | |
| electrified operation | In electrified operation , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration Receives: Diagnostic Test: vital signs monitoring | |
| work site | In work site , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration Receives: Diagnostic Test: vital signs monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory rate
Breaths per minute
Measured: 3 month
heart rate
beats per minute
Measured: 3 month
blood oxygen saturation
Concentration of oxygen in the blood
Measured: 3 month
electromyography
Measurement and analysis of electromyographic signals emitted during muscle contraction
Measured: 3 month
electroencephalogram
Collecting brainwave signals，Analyze the EEG for abnormalities
Measured: 3 month
Partial pressure of end-expiratory CO2 concentration
Measurement of the partial pressure of CO2 in exhaled gas at the end of expiration
Measured: 3 month
transcutaneous partial pressure of oxygen
Measurement of the partial pressure of oxygen at the skin surface, thus indirectly reflecting the state of tissue oxygenation
Measured: 3 month
Percutaneous carbon dioxide partial pressure
Indirectly reflecting the partial pressure of carbon dioxide by measuring the pH of the skin surface
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate MonitoringStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- luan xiaorong, Study chair, Shandong University Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076057
- Sponsor's protocol ID
- 2021CXGC011301
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Monitoring of Emergency Responders in Different States
- ClinicalTrials.gov ID
- NCT06076057
- Acronym / sponsor ID
- 2021CXGC011301
- Conditions
- Heart Rate Monitoring
- Keywords
- Vital Signs, Respiration, transcutaneous oxygenation, end-expiratory carbon dioxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are:
- Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.
- Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.
Participants will normal operating conditions, the researcher collects vital sign information.
Detailed description
- General information: name, age, height, weight, place of origin, smoking history, and whether or not they snore.
- 10 vital signs and behavioral parameters in different states (quiet, after duty, after physical training), including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, partial pressure of transcutaneous carbon dioxide.
- 8 vital signs and behavioral parameters in different environments (overhead, confined space, energized work, work site), including: respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 8:00 Measurement team | – | Diagnostic Test: vital signs monitoringAt 08:00 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. |
| 10:30 Measurement team | – | Diagnostic Test: vital signs monitoringAt 10:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. |
| 16:30 Measurement team | – | Diagnostic Test: vital signs monitoringAt 16:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. |
| high altitude environment | – | Diagnostic Test: vital signs monitoringIn high altitude environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration |
| limited space | – | Diagnostic Test: vital signs monitoringIn limited space environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration |
| electrified operation | – | Diagnostic Test: vital signs monitoringIn electrified operation , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration |
| work site | – | Diagnostic Test: vital signs monitoringIn work site , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Frontline National Grid Emergency Responders
Key inclusion criteria (2 listed)
- No history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia.
- Voluntarily participated in this study and signed an informed consent form
Key exclusion criteria (1 listed)
- Patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vital signs monitoringMonitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors | Diagnostic test | 10:30 Measurement team, 16:30 Measurement team, 8:00 Measurement team, electrified operation, high altitude environment, limited space, work site |
Primary outcome
respiratory rate
Time frame: 3 month
Breaths per minute
heart rate
Time frame: 3 month
beats per minute
blood oxygen saturation
Time frame: 3 month
Concentration of oxygen in the blood
electromyography
Time frame: 3 month
Measurement and analysis of electromyographic signals emitted during muscle contraction
electroencephalogram
Time frame: 3 month
Collecting brainwave signals，Analyze the EEG for abnormalities
Partial pressure of end-expiratory CO2 concentration
Time frame: 3 month
Measurement of the partial pressure of CO2 in exhaled gas at the end of expiration
transcutaneous partial pressure of oxygen
Time frame: 3 month
Measurement of the partial pressure of oxygen at the skin surface, thus indirectly reflecting the state of tissue oxygenation
Percutaneous carbon dioxide partial pressure
Time frame: 3 month
Indirectly reflecting the partial pressure of carbon dioxide by measuring the pH of the skin surface
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
luan xiaorong study chair
Shandong University Qilu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Monitoring, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma dedong (18560082806, ma@qiluhuxi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory rate (time frame: 3 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.