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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06076057
Other study ID # 2021CXGC011301
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2023
Est. completion date February 1, 2024

Study information

Verified date September 2023
Source Qilu Hospital of Shandong University
Contact Ma dedong
Phone 18560082806
Email ma@qiluhuxi.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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, 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.


Description:

1. General information: name, age, height, weight, place of origin, smoking history, and whether or not they snore. 2. 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. 3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date February 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
vital signs monitoring
Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors

Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Shan Dong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary respiratory rate Breaths per minute 3 month
Primary heart rate beats per minute 3 month
Primary blood oxygen saturation Concentration of oxygen in the blood 3 month
Primary electromyography Measurement and analysis of electromyographic signals emitted during muscle contraction 3 month
Primary electroencephalogram Collecting brainwave signals,Analyze the EEG for abnormalities 3 month
Primary Partial pressure of end-expiratory CO2 concentration Measurement of the partial pressure of CO2 in exhaled gas at the end of expiration 3 month
Primary transcutaneous partial pressure of oxygen Measurement of the partial pressure of oxygen at the skin surface, thus indirectly reflecting the state of tissue oxygenation 3 month
Primary Percutaneous carbon dioxide partial pressure Indirectly reflecting the partial pressure of carbon dioxide by measuring the pH of the skin surface 3 month
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