Awaken Prone Positioning Ventinlation in COVID-19 Patients

NCT ID: NCT05677984

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2023-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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APP group

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

Group Type EXPERIMENTAL

Awaken prone positioning ventilation

Intervention Type PROCEDURE

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

Control group

No intervention on APP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Awaken prone positioning ventilation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Ling Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haibo QIU, Dr

Role: STUDY_DIRECTOR

Southeast University

Locations

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Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40549277 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39088076 (View on PubMed)

Other Identifiers

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20221227

Identifier Type: -

Identifier Source: org_study_id

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