Acute Respiratory FailureNCT05570903
A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure
An observational study of Acute Respiratory Failure, run by First Affiliated Hospital of Zhejiang University.
Trial summary
Awake prone positioning has been used widely for patients with COVID-19.Many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with SARS-CoV-2 infected who are not intubated.The investigators will conduct a prospective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 9 Sep 2025
- 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
- Adult, Older adult
Study population: Acute and critical patients transferred from primary hospitals or admitted to emergency departments
Who may be able to join
- 1.Older than 17 years, admitted to the ICU;2.Patients with acute respiratory failure meet the following conditions：①Under the condition of breathing air at rest, PaO2 of subjects is lower than 60mmHg and/or PaCO2 is higher than 50mmHg; ②Under the support of COT and HFNC, PaO2/FiO2 of the subject is less than 250; ③ Under the support of NIV ;
Who cannot join
- 1.Refusing to cooperate with active treatment; 2.Immediate need for intubation as determined by the treating team.3Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)；4.Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury)；
About this study
Awake prone positioning has been used widely for patients with COVID-19.Many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with SARS-CoV-2 infected who are not intubated.The investigators will conduct a prospective observational study on patients with acute respiratory failure induced by various causes to determine whether awake prone position can reduce the need to upgrade to invasive mechanical ventilation and improve the prognosis of patients compared with standard treatment.
- Conditions
- Acute Respiratory Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Awake prone position Group | Patients in awake prone position will be included. | |
| Non awake prone position Group | Patients in non awake prone position will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation rate
Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation
Measured: 28 days
Mortality
Death
Measured: 28 days
Secondary outcomes (6)
Total hours of prone position at day
Total hours of prone position at day
Measured: 28 days
Total number of prone sessions at day
Total number of prone sessions at day
Measured: 28 days
Total days of prone positioning therapy
Total days of prone positioning therapy
Measured: 28 days
Non-invasive ventilation days
Number of days not receiving non-invasive mechanical ventilation
Measured: 28 days
Change in the ROX-index 1-hour after first prone session
The change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index)
Measured: 1 hour
Total length of stay in ICU and hospital
Total length of stay in ICU and hospital
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Qiang Lu, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570903
- Sponsor's protocol ID
- luyuanqiang
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT05570903
- Acronym / sponsor ID
- luyuanqiang
- Conditions
- Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 7 Oct 2022 (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.
Awake prone positioning has been used widely for patients with COVID-19.Many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with SARS-CoV-2 infected who are not intubated.The investigators will conduct a prospective observational study on patients with acute respiratory failure induced by various causes to determine whether awake prone position can reduce the need to upgrade to invasive mechanical ventilation and improve the prognosis of patients compared with standard treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake prone position Group | – | –Patients in awake prone position will be included. |
| Non awake prone position Group | – | –Patients in non awake prone position will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute and critical patients transferred from primary hospitals or admitted to emergency departments
Key inclusion criteria (1 listed)
- 1.Older than 17 years, admitted to the ICU;2.Patients with acute respiratory failure meet the following conditions：①Under the condition of breathing air at rest, PaO2 of subjects is lower than 60mmHg and/or PaCO2 is higher than 50mmHg; ②Under the support of COT and HFNC, PaO2/FiO2 of the subject is less than 250; ③ Under the support of NIV ;
Key exclusion criteria (1 listed)
- 1.Refusing to cooperate with active treatment; 2.Immediate need for intubation as determined by the treating team.3Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)；4.Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury)；
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
Endotracheal intubation rate
Time frame: 28 days
Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation
Mortality
Time frame: 28 days
Death
6 secondary outcomes
Total hours of prone position at day
Time frame: 28 days
Total number of prone sessions at day
Time frame: 28 days
Total days of prone positioning therapy
Time frame: 28 days
Non-invasive ventilation days
Time frame: 28 days
Change in the ROX-index 1-hour after first prone session
Time frame: 1 hour
Total length of stay in ICU and hospital
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by First Affiliated Hospital of Zhejiang University.
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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Endotracheal intubation rate (time frame: 28 days). 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 10 Oct 2022.