Noninvasive VentilationNCT03250416
Management of Noninvasive Ventilation in Hypoxemic Patients
An observational study of Noninvasive Ventilation, run by Chongqing Medical University at 1 site in China.
Trial summary
The investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation
- How many people
- 2,179 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Sep 2021
- How long will I take part?
- 30 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The main population is acute hypoxemic respiratory failure. The subgroup included ARDS, pneumonia, sepsis and so on.
Who may be able to join
- PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25 breaths/min or presence of labored breath.
Who cannot join
- Requirement of emergency intubation; Sequential use of noninvasive ventilation after extubation;Use of noninvasive ventilation after accident extubation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital ,Chongqing Medical Univercity
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The First Affiliated Hospital of Chongqing Medical University
The investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure.
Read the detailed description
Patients with hypoxemic respiratory failure were enrolled in this study. The investigator collected the data at beginning and first stage of noninvasive ventilation to analyze the efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the investigator also aimed to develop a scale to predict the efficacy of noninvasive ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.
- Conditions
- Noninvasive Ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive ventilation failure
Noninvasive ventilation failure was defined as requirement of intubation.
Measured: From participation to 30 days
Secondary outcomes (2)
Mortality
Mortality in ICU and hospital
Measured: From participation to 30 days
ICU stay
Length of ICU stay
Measured: From participation to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,179 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duan jun, Chongqing Medical University
- Investigators
- Jun Duan, Dr, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250416
- Sponsor's protocol ID
- ChongqingMU2
- Status last verified
- Jul 2022
- First submitted
- 11 Aug 2017
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT03250416
- Acronym / sponsor ID
- ChongqingMU2
- Conditions
- Noninvasive Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,179 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Aug 2017 (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.
The investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure.
Detailed description
Patients with hypoxemic respiratory failure were enrolled in this study. The investigator collected the data at beginning and first stage of noninvasive ventilation to analyze the efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the investigator also aimed to develop a scale to predict the efficacy of noninvasive ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The main population is acute hypoxemic respiratory failure. The subgroup included ARDS, pneumonia, sepsis and so on.
Key inclusion criteria (1 listed)
- PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25 breaths/min or presence of labored breath.
Key exclusion criteria (1 listed)
- Requirement of emergency intubation; Sequential use of noninvasive ventilation after extubation;Use of noninvasive ventilation after accident extubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Noninvasive ventilation failure
Time frame: From participation to 30 days
Noninvasive ventilation failure was defined as requirement of intubation.
2 secondary outcomes
Mortality
Time frame: From participation to 30 days
ICU stay
Time frame: From participation to 30 days
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 7 Jul 2022.
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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.
Jun Duan, Dr principal investigator
First Affiliated Hospital of Chongqing 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 Noninvasive Ventilation, run by Chongqing 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 1 inclusion and 1 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 7 Jul 2022. 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?
Noninvasive ventilation failure (time frame: From participation to 30 days). 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 7 Jul 2022.