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CompletedNCT05677984Updated Sep 5, 2023

Awaken Prone Positioning Ventinlation in COVID-19 Patients

An interventional study of Awaken prone positioning ventilation in COVID-19, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
409
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • COVID-19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 409 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
409 participants (actual)

Study arms

  • Experimental
    APP group

    Directive APP for a target of 12 hours per day or more

    Procedure: Awaken prone positioning ventilation

  • No intervention
    Control group

    No intervention on APP

Interventions

  • ProcedureAwaken prone positioning ventilation

    patients were mandated to keep a prone position for at least 12 hours.

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What researchers measure

Primary outcomes

  1. 28-day intubation rate

    whether the patients' were intubated

    Time frame: follow-up till 28-day

Secondary outcomes

  1. APP duration/days

    hours of APP per day

    Time frame: follow-up till APP ended, daily duration of APP also recoreded, up to 7 days

  2. 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

    Time frame: follow-up till 28-day

  3. mortality (ICU hospital) length of ICU (hospital) stay

    mortality AND mortality and length of stay at 28 day

    Time frame: follow-up during the ICU/hospital stay, up to 28 days

Other outcomes

  1. Adverse events of interest

    All adverse events of interest that occur in both randomised arms will be reported up to day 28 post-randomisation, including the following: * Nausea, * Unintentional removal of intravenous access, * Pressure ulcer, * Unexpected respiratory cardiac arrest Nausea, Unintentional removal of intravenous access, Pressure ulcer,Unexpected respiratory cardiac arrest

    Time frame: 28 post-randomisation

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Study locations

1 site
  • Southeast University
    Nanjing, Jiangsu 210009, China
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References and documents

Individual participant data

Plan to share: Yes — from the email:liulingdoctor@126.com

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05677984
Lead sponsor
Southeast University, China
Responsible party
Ling Liu (Professor, Southeast University, China) — Principal investigator
First posted
Jan 10, 2023
Start date
Jan 11, 2023
Primary completion
Apr 30, 2023
Completion
May 30, 2023
Last update
Sep 5, 2023

Study contacts

Haibo QIU, Dr
study director · Southeast University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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