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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shan Dong
      • Jinan, Shan Dong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
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
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.
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
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
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
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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