- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076057
Vital Signs Monitoring of Emergency Responders in Different States
October 6, 2023 updated by: Qilu Hospital of Shandong University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ma dedong
- Phone Number: 18560082806
- Email: ma@qiluhuxi.com
Study Locations
-
-
Shan Dong
-
Jinan, Shan Dong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- Li yang
- Phone Number: 15688880756
- Email: ly974122@163.com
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Frontline National Grid Emergency Responders
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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.
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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.
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
|
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
|
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
respiratory rate
Time Frame: 3 month
|
Breaths per minute
|
3 month
|
|
heart rate
Time Frame: 3 month
|
beats per minute
|
3 month
|
|
blood oxygen saturation
Time Frame: 3 month
|
Concentration of oxygen in the blood
|
3 month
|
|
electromyography
Time Frame: 3 month
|
Measurement and analysis of electromyographic signals emitted during muscle contraction
|
3 month
|
|
electroencephalogram
Time Frame: 3 month
|
Collecting brainwave signals,Analyze the EEG for abnormalities
|
3 month
|
|
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
|
3 month
|
|
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
|
3 month
|
|
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
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: luan xiaorong, Shandong University Qilu Hospital
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 (Estimated)
October 15, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
October 6, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021CXGC011301
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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