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Awaken Prone Positioning Ventinlation in COVID-19 Patients

S

Southeast University, China

Status

Completed

Conditions

COVID-19

Treatments

Procedure: Awaken prone positioning ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT05677984
20221227

Details and patient eligibility

About

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.

Enrollment

409 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

409 participants in 2 patient groups

APP group
Experimental group
Description:
Directive APP for a target of 12 hours per day or more
Treatment:
Procedure: Awaken prone positioning ventilation
Control group
No Intervention group
Description:
No intervention on APP

Trial contacts and locations

1

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Central trial contact

Wei Chang, Dr.; Liu Ling, Professor

Data sourced from clinicaltrials.gov

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