COVID-19NCT05677984
Awaken Prone Positioning Ventinlation in COVID-19 Patients
A study testing Awaken prone positioning ventilation in people with COVID-19, run by Southeast University, China at 1 site in China.
Trial summary
Awaken prone positioning (APP) ventilation has been widely accepted as a standard regimen in the management of COVID-19 patients. Physiological studies have proved ventilation/perfusion improvement during APP in COVID-19, which was associated improved oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Awaken prone positioning ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 30 May 2023
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18-yr to 85-yr
- Severe COVID-19 pneumonia (with typical radiographic alternations) and non-intubated patients.
- SpO2 <= 93% with ambient air at rest.
- PaO2/FiO2 <= 300 mmHg
Who cannot join
- Definite intolerance to APP (e.g. pregnancy, extremity deformity, recent fracture, open thoracic or abdominal surgery, pace-maker implant in recent 48-hr, spine stability, pelvis or facial fractures, predicted difficult airway)
- morbidity obesity, BMI > 40
- consciousness disorder (GCS < 13), delirium dementia
- hemodynamic instability (with norepinephrine >20 ug/min )
- NYHA Grade III or IV
- Severe hemoptysis
- long term home oxygenation of CPAP
- Refuse invasive mechanical ventilation (DNI DNR)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study
Awaken prone positioning (APP) ventilation has been widely accepted as a standard regimen in the management of COVID-19 patients. Physiological studies have proved ventilation/perfusion improvement during APP in COVID-19, which was associated improved oxygenation. However, the optimal duration for APP was not yet demonstrated. In this study, we aimed at the prolonged APP to see whether this could improve patients outcomes.
- Conditions
- COVID-19
- Being tested
- Awaken prone positioning ventilation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awaken prone positioning ventilationProcedure or surgery
patients were mandated to keep a prone position for at least 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| APP group | Experimental | Directive APP for a target of 12 hours per day or more Receives: Procedure: Awaken prone positioning ventilation |
| Control group | No intervention | No intervention on APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day intubation rate
whether the patients' were intubated
Measured: follow-up till 28-day
Secondary outcomes (3)
APP duration/days
hours of APP per day
Measured: follow-up till APP ended, daily duration of APP also recoreded, up to 7 days
Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication
Whether to apply these treatments，any complications occur,days free from respiratory support and days free from invasive mechanical ventilation at 28 day
Measured: follow-up till 28-day
mortality (ICU hospital) length of ICU (hospital) stay
mortality AND mortality and length of stay at 28 day
Measured: follow-up during the ICU/hospital stay, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start11 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Haibo QIU, Dr, Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677984
- Sponsor's protocol ID
- 20221227
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: from the email：liulingdoctor@126.com
Publications
Sun Q, Zhang R, Zhang J, Xie J, Huang Y, Yang Y, Qiu H, Liu L, Chen H; Chi-ARDS Net (Chinese ARDS Research Network). Impact of awake prone positioning duration on intubation or mortality in COVID-19 patients with acute respiratory failure: secondary analysis of a randomized clinical trial. Ann Intensive Care. 2025 Jun 23;15(1):84. doi: 10.1186/s13613-025-01501-8.
PubMed 40549277Liu L, Sun Q, Zhao H, Liu W, Pu X, Han J, Yu J, Jin J, Chao Y, Wang S, Liu Y, Wu B, Zhu Y, Li Y, Chang W, Chen T, Xie J, Yang Y, Qiu H, Slutsky A; Chi-ARDS Net (Chinese ARDS Research Network). Prolonged vs shorter awake prone positioning for COVID-19 patients with acute respiratory failure: a multicenter, randomised controlled trial. Intensive Care Med. 2024 Aug;50(8):1298-1309. doi: 10.1007/s00134-024-07545-x. Epub 2024 Aug 1.
PubMed 39088076
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05677984
- Acronym / sponsor ID
- 20221227
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 10 Jan 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.
Awaken prone positioning (APP) ventilation has been widely accepted as a standard regimen in the management of COVID-19 patients. Physiological studies have proved ventilation/perfusion improvement during APP in COVID-19, which was associated improved oxygenation. However, the optimal duration for APP was not yet demonstrated. In this study, we aimed at the prolonged APP to see whether this could improve patients outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP group | Experimental | Procedure: Awaken prone positioning ventilationDirective APP for a target of 12 hours per day or more |
| Control group | No intervention | –No intervention on APP |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged > 18-yr to 85-yr
- Severe COVID-19 pneumonia (with typical radiographic alternations) and non-intubated patients.
- SpO2 <= 93% with ambient air at rest.
- PaO2/FiO2 <= 300 mmHg
Key exclusion criteria (8 listed)
- Definite intolerance to APP (e.g. pregnancy, extremity deformity, recent fracture, open thoracic or abdominal surgery, pace-maker implant in recent 48-hr, spine stability, pelvis or facial fractures, predicted difficult airway)
- morbidity obesity, BMI > 40
- consciousness disorder (GCS < 13), delirium dementia
- hemodynamic instability (with norepinephrine >20 ug/min )
- NYHA Grade III or IV
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 |
|---|---|---|
| Awaken prone positioning ventilationpatients were mandated to keep a prone position for at least 12 hours. | Procedure or surgery | APP group |
Primary outcome
28-day intubation rate
Time frame: follow-up till 28-day
whether the patients' were intubated
3 secondary outcomes
APP duration/days
Time frame: follow-up till APP ended, daily duration of APP also recoreded, up to 7 days
Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication
Time frame: follow-up till 28-day
mortality (ICU hospital) length of ICU (hospital) stay
Time frame: follow-up during the ICU/hospital stay, up to 28 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 5 Sep 2023.
- Derived from this study: PubMed 40549277Sun Q, Zhang R, Zhang J, Xie J, Huang Y, Yang Y, Qiu H, Liu L, Chen H; Chi-ARDS Net (Chinese ARDS Research Network). Impact of awake prone positioning duration on intubation or mortality in COVID-19 patients with acute respiratory failure: secondary analysis of a randomized clinical trial. Ann Intensive Care. 2025 Jun 23;15(1):84. doi: 10.1186/s13613-025-01501-8.
- Derived from this study: PubMed 39088076Liu L, Sun Q, Zhao H, Liu W, Pu X, Han J, Yu J, Jin J, Chao Y, Wang S, Liu Y, Wu B, Zhu Y, Li Y, Chang W, Chen T, Xie J, Yang Y, Qiu H, Slutsky A; Chi-ARDS Net (Chinese ARDS Research Network). Prolonged vs shorter awake prone positioning for COVID-19 patients with acute respiratory failure: a multicenter, randomised controlled trial. Intensive Care Med. 2024 Aug;50(8):1298-1309. doi: 10.1007/s00134-024-07545-x. Epub 2024 Aug 1.
- Individual participant dataSharing planned: Yes. from the email：liulingdoctor@126.com
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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.
Haibo QIU, Dr study director
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awaken prone positioning ventilation in people with COVID-19, run by Southeast University, China 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 5 Sep 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?
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?
28-day intubation rate (time frame: follow-up till 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677984, which also lists 2 linked publications.
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 5 Sep 2023.