NCT05677984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

January 3, 2023

Last Update Submit

August 30, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 28-day intubation rate

    whether the patients' were intubated

    follow-up till 28-day

Secondary Outcomes (3)

  • APP duration/days

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

  • Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication

    follow-up till 28-day

  • mortality (ICU hospital) length of ICU (hospital) stay

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

Other Outcomes (1)

  • Adverse events of interest

    28 post-randomisation

Study Arms (2)

APP group

EXPERIMENTAL

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

Procedure: Awaken prone positioning ventilation

Control group

NO INTERVENTION

No intervention on APP

Interventions

Awaken prone positioning ventilationPROCEDURE

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

APP group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (2)

  • Sun Q, Zhang R, Zhang J, Xie J, Huang Y, Yang Y, Qiu H, Liu L, Chen H; Chi-ARDS Net (Chinese ARDS Research Network). Impact of awake prone positioning duration on intubation or mortality in COVID-19 patients with acute respiratory failure: secondary analysis of a randomized clinical trial. Ann Intensive Care. 2025 Jun 23;15(1):84. doi: 10.1186/s13613-025-01501-8.

    PMID: 40549277DERIVED

  • Liu L, Sun Q, Zhao H, Liu W, Pu X, Han J, Yu J, Jin J, Chao Y, Wang S, Liu Y, Wu B, Zhu Y, Li Y, Chang W, Chen T, Xie J, Yang Y, Qiu H, Slutsky A; Chi-ARDS Net (Chinese ARDS Research Network). Prolonged vs shorter awake prone positioning for COVID-19 patients with acute respiratory failure: a multicenter, randomised controlled trial. Intensive Care Med. 2024 Aug;50(8):1298-1309. doi: 10.1007/s00134-024-07545-x. Epub 2024 Aug 1.

    PMID: 39088076DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Haibo QIU, Dr

    Southeast University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 10, 2023

Study Start

January 11, 2023

Primary Completion

April 30, 2023

Study Completion

May 30, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

from the email：liulingdoctor@126.com

Time Frame
Starting from the official publication of the manuscript to 1 year later
Access Criteria
collaborator

Locations

CN(1)