Respiratory FailureNCT04053777
Clinical Assessment Method in Patients Using Non-invasive Ventilation
An observational study of Respiratory Failure, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- non-invasive ventilation
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 15 Sep 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypercapnic respiratory failure who need to use non-invasive ventilation.
Who may be able to join
- Age 18-80, males and females
- Patients with hypercapnic respiratory failure
- Willing to participate in the study.
- Being able to provide informed consent.
Who cannot join
- Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
- Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
- Subjects who participated in another trial within 30 days prior to the planned start of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510000
Rongchang Chen, +8615622236759, chenrcstatekeylab@gmail.com
About this study
Official title: Establishment and Validation of the Clinical Assessment Method in Patients Using Non-invasive Ventilation
This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.
Read the detailed description
Non-invasive positive pressure ventilation (NPPV) is undoubtedly one of the most important advances in mechanical ventilation technology in the past 30 years. Currently, NPPV has become an essential respiratory support technology in hospitals, and it is used in different fields, including respiratory and critical care, emergency care, anesthesia, and rehabilitation. Applications of NPPV are also gradually expanding from intensive care units (ICUs) and respiratory wards to use in other medical departments and at home.
This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.
- Conditions
- Respiratory Failure
- Being tested
- non-invasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationDevice
Noninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease.
| Study group | Role | What they receive |
|---|---|---|
| NIV group | Patients receiving non-invasive ventilation in the hospital or at home Receives: Device: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of visual analogue scale score before and after using non-invasive ventilation
Visual analogue scale score is used to represent the subjective dyspnea of patient. Scores range between 0 and 10 and higher scores are attributed to less dyspnea.
Measured: 1 hour
Secondary outcomes (4)
Changes of respiratory rate before and after using non-invasive ventilation
The respiratory rate is the rate at which breathing occurs. This is usually measured in breaths per minute.
Measured: 1 hour
Changes of SpO2 before and after using non-invasive ventilation
Oxygen saturation is the fraction of [oxygen]-saturated hemoglobin relative to total hemoglobin in the blood.
Measured: 1 hour
Changes of tidal volume before and after using non-invasive ventilation
Tidal volume is the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied.This is usually measured in mini Liter.
Measured: 1 hour
Changes of heart rate before and after using non-invasive ventilation
Heart rate is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start20 Aug 2019
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guan Lili, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053777
- Sponsor's protocol ID
- GIRH-NIV201906
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Validation of the Clinical Assessment Method in Patients Using Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT04053777
- Acronym / sponsor ID
- GIRH-NIV201906
- Conditions
- Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 13 Aug 2019 (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.
This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.
Detailed description
Non-invasive positive pressure ventilation (NPPV) is undoubtedly one of the most important advances in mechanical ventilation technology in the past 30 years. Currently, NPPV has become an essential respiratory support technology in hospitals, and it is used in different fields, including respiratory and critical care, emergency care, anesthesia, and rehabilitation. Applications of NPPV are also gradually expanding from intensive care units (ICUs) and respiratory wards to use in other medical departments and at home.
This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIV group | – | Device: non-invasive ventilationPatients receiving non-invasive ventilation in the hospital or at home |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypercapnic respiratory failure who need to use non-invasive ventilation.
Key inclusion criteria (4 listed)
- Age 18-80, males and females
- Patients with hypercapnic respiratory failure
- Willing to participate in the study.
- Being able to provide informed consent.
Key exclusion criteria (3 listed)
- Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
- Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
- Subjects who participated in another trial within 30 days prior to the planned start of the study
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 |
|---|---|---|
| non-invasive ventilationNoninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease. | Device | NIV group |
Primary outcome
Changes of visual analogue scale score before and after using non-invasive ventilation
Time frame: 1 hour
Visual analogue scale score is used to represent the subjective dyspnea of patient. Scores range between 0 and 10 and higher scores are attributed to less dyspnea.
4 secondary outcomes
Changes of respiratory rate before and after using non-invasive ventilation
Time frame: 1 hour
Changes of SpO2 before and after using non-invasive ventilation
Time frame: 1 hour
Changes of tidal volume before and after using non-invasive ventilation
Time frame: 1 hour
Changes of heart rate before and after using non-invasive ventilation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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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.
Rongchang Chen, MD study chair
The First Affiliated Hospital of Guangzhou Medical University
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 Respiratory Failure, run by The First Affiliated Hospital of Guangzhou Medical 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 4 inclusion and 3 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 23 Oct 2019. 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 Lili Guan, PhD (+8613422288665, nickguanll@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of visual analogue scale score before and after using non-invasive ventilation (time frame: 1 hour). 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 23 Oct 2019.