Awaken Prone Positioning Ventinlation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677984
• Other study ID #: 20221227
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: August 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Awaken prone positioning ventilation
patients were mandated to keep a prone position for at least 12 hours.

Locations

Country	Name	City	State
China	Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	28 post-randomisation
Primary	28-day intubation rate	whether the patients' were intubated	follow-up till 28-day
Secondary	APP duration/days	hours of APP per day	follow-up till APP ended, daily duration of APP also recoreded, up to 7 days
Secondary	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	follow-up till 28-day
Secondary	mortality (ICU hospital) length of ICU (hospital) stay	mortality AND mortality and length of stay at 28 day	follow-up during the ICU/hospital stay, up to 28 days