Respiratory Distress SyndromeNCT05715788
Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.
An observational study of Respiratory Distress Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Nitric oxide and prone positioning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2022to Dec 2023
- 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: Patients with COVID-19 associated ARDS
Who may be able to join
- Adult patients with COVID-19 associated ARDS
Who cannot join
- patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Zhong, PhD, 021-65642662, zhong.ming@zs-hospital.sh.cn
About this study
Official title: Prone Positioning Versus Prone Positioning and NO Inhalation in COVID-19 Associated Acute Respiratory Distress Syndrome.
The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.
Read the detailed description
The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Nitric oxide, prone positioning
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric oxideDrug
Nitric oxide inhalation at 20 ppm
prone positioningBehavioural
Also called PPV
vatilation in prone position
| Study group | Role | What they receive |
|---|---|---|
| patients ventilated in prone position | Patients ventilated in prone position Receives: Behavioral: prone positioning | |
| Patients ventilated in prone position with NO inhalation | Patients ventilated in prone position with NO inhalation Receives: Drug: Nitric oxide; Behavioral: prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
P/F ratio
P/F ratios in each group
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start21 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715788
- Sponsor's protocol ID
- ppv-vs-ppvno
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning Versus Prone Positioning and NO Inhalation in COVID-19 Associated Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT05715788
- Acronym / sponsor ID
- ppv-vs-ppvno
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (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 investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.
Detailed description
The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients ventilated in prone position | – | Behavioral: prone positioningPatients ventilated in prone position |
| Patients ventilated in prone position with NO inhalation | – | Drug: Nitric oxide, Behavioral: prone positioningPatients ventilated in prone position with NO inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 associated ARDS
Key inclusion criteria (1 listed)
- Adult patients with COVID-19 associated ARDS
Key exclusion criteria (1 listed)
- patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure
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 |
|---|---|---|
| Nitric oxideNitric oxide inhalation at 20 ppm | Drug | Patients ventilated in prone position with NO inhalation |
| prone positioningAlso: PPVvatilation in prone position | Behavioural | Patients ventilated in prone position with NO inhalation, patients ventilated in prone position |
Primary outcome
P/F ratio
Time frame: 16 hours
P/F ratios in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Ming Zhong, PhD study chair
Fudan 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 Distress Syndrome, run by Shanghai Zhongshan Hospital 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 Ming Zhong, PhD ((021) 6564 2662, zhong.ming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P/F ratio (time frame: 16 hours). 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 8 Feb 2023.