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Awaken Prone Positioning Ventinlation in COVID-19 Patients

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Awaken prone positioning ventilation
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

APP group

Control group

Arm Description

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

No intervention on APP

Outcomes

Primary Outcome Measures

28-day intubation rate
whether the patients' were intubated

Secondary Outcome Measures

APP duration/days
hours of APP per day
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
mortality (ICU hospital) length of ICU (hospital) stay
mortality AND mortality and length of stay at 28 day

Full Information

First Posted
January 3, 2023
Last Updated
August 30, 2023
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05677984
Brief Title
Awaken Prone Positioning Ventinlation in COVID-19 Patients
Official Title
Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APP group
Arm Type
Experimental
Arm Description
Directive APP for a target of 12 hours per day or more
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention on APP
Intervention Type
Procedure
Intervention Name(s)
Awaken prone positioning ventilation
Intervention Description
patients were mandated to keep a prone position for at least 12 hours.
Primary Outcome Measure Information:
Title
28-day intubation rate
Description
whether the patients' were intubated
Time Frame
follow-up till 28-day
Secondary Outcome Measure Information:
Title
APP duration/days
Description
hours of APP per day
Time Frame
follow-up till APP ended, daily duration of APP also recoreded, up to 7 days
Title
Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication
Description
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
Title
mortality (ICU hospital) length of ICU (hospital) stay
Description
mortality AND mortality and length of stay at 28 day
Time Frame
follow-up during the ICU/hospital stay, up to 28 days
Other Pre-specified Outcome Measures:
Title
Adverse events of interest
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo QIU, Dr
Organizational Affiliation
Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Awaken Prone Positioning Ventinlation in COVID-19 Patients

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