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Completed

NCT Number: NCT05677984

Awaken Prone Positioning Ventinlation in COVID-19 Patients

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeast University

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Awaken prone positioning ventilation

Procedure

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

Primary outcomes

  1. 28-day intubation rate

    Time frame: follow-up till 28-day

    whether the patients' were intubated

Secondary outcomes

  1. APP duration/days

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

    hours of APP per day

  2. Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication

    Time frame: follow-up till 28-day

    Whether to apply these treatments，any complications occur,days free from respiratory support and days free from invasive mechanical ventilation at 28 day

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

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

    mortality AND mortality and length of stay at 28 day

Other outcomes

  1. Adverse events of interest

    Time frame: 28 post-randomisation

    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

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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