Awaken Prone Positioning Ventinlation in COVID-19 Patients

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Procedure: Awaken prone positioning ventilation

• Study Type: Interventional
• Enrollment (Actual): 409
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Southeast university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APP group; Directive APP for a target of 12 hours per day or more	Procedure: Awaken prone positioning ventilation; patients were mandated to keep a prone position for at least 12 hours.
No Intervention: Control group; No intervention on APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day intubation rate	whether the patients' were intubated	follow-up till 28-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APP duration/days	hours of APP per day	follow-up till APP ended, daily duration of APP also recoreded, up to 7 days
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Haibo QIU, Dr, Southeast university

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20221227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: from the email：liulingdoctor@126.com
• IPD Sharing Time Frame: Starting from the official publication of the manuscript to 1 year later
• IPD Sharing Access Criteria: collaborator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No