Noninvavie Ventilation to Patients With COVID-19NCT04568655
The Noninvasive Ventilation to COVID-19 Patients
An observational study of Noninvavie Ventilation to Patients With COVID-19, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Noninvavie Ventilation to Patients With COVID-19
- What is being tested?
- noninvasive ventilation
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Jul 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: respiratory failure patients with COVID-19
Who may be able to join
- Shortness of breath, RR>30 times per minute;
- At room air, SpO2 lower than 93%;
- The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) ≤ 300mmHg;
- CT（computed tomography） chest imaging shows that lung damage develops significantly within 24 to 48 hours.
Who cannot join
- Severe cardiovascular disease,
- respiratory arrest,
- cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
- change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
- secretions,
- recent facial or gastroesophageal surgery,
- craniofacial trauma, 8)fixed nasopharyngeal abnormalities,
- 9）burns, 10) extreme obesity.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 520120
About this study
Official title: The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.
Read the detailed description
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.
- Being tested
- noninvasive ventilation
- Keywords
- noninvavie ventilation, COVID-19, respiratory failure
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive ventilationDevice
noninvasive ventilation to support the COVID-19 patients with respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients need noninvasive ventilation | Not described Receives: Device: noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
the sucess rate of the noninvasive ventilation
Measured: 4 month
the intubtion rate
the intubtion rate of the COVID-19 patients
Measured: 4 month
Secondary outcomes (4)
blood lymphocyte
blood lymphocyte of the COVID-19 patients
Measured: 4month
B-type natriuretic peptide
blood B-type natriuretic peptide of the COVID-19 patients
Measured: 4 month
Procalcitonin
blood procalcitonin of the COVID-19 patients
Measured: 4 month
Oxygen Saturation
Oxygen Saturation of the COVID-19 patients
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvavie Ventilation to Patients With COVID-19Studies 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
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568655
- Sponsor's protocol ID
- FAHGuangzhouYLS03
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the IPD are going to share after the paper published.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT04568655
- Acronym / sponsor ID
- FAHGuangzhouYLS03
- Keywords
- noninvavie ventilation, COVID-19, respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 29 Sep 2020 (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.
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.
Detailed description
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients need noninvasive ventilation | – | Device: noninvasive ventilation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- respiratory failure patients with COVID-19
Key inclusion criteria (4 listed)
- Shortness of breath, RR>30 times per minute;
- At room air, SpO2 lower than 93%;
- The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) ≤ 300mmHg;
- CT（computed tomography） chest imaging shows that lung damage develops significantly within 24 to 48 hours.
Key exclusion criteria (8 listed)
- Severe cardiovascular disease,
- respiratory arrest,
- cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
- change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
- secretions,
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 |
|---|---|---|
| noninvasive ventilationnoninvasive ventilation to support the COVID-19 patients with respiratory failure | Device | COVID-19 patients need noninvasive ventilation |
Primary outcome
success rate
Time frame: 4 month
the sucess rate of the noninvasive ventilation
the intubtion rate
Time frame: 4 month
the intubtion rate of the COVID-19 patients
4 secondary outcomes
blood lymphocyte
Time frame: 4month
B-type natriuretic peptide
Time frame: 4 month
Procalcitonin
Time frame: 4 month
Oxygen Saturation
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: Undecided. the IPD are going to share after the paper published.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Noninvavie Ventilation to Patients With COVID-19, 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 8 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: finished, as of the sponsor's last update on 29 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 4 month). The study lists 2 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 29 Sep 2020.