Timings for Awake Prone Positioning in Covid-19 Patients

NCT05795751 | Completed

• 1 other identifier: ZWQ21886
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 is an infectious disease caused by a virus called SARS-CoV-2. The spread rate and mortality rate of the virus have had a significant impact on global health and economic systems. Comprehensive treatment and supportive care are required to help COVID-19 patients recover. During the treatment of COVID-19, the respiratory system of patients may be affected, and measures need to be taken to support respiratory function. Currently, awake prone positioning(APP) is an effective method for treating respiratory failure when mechanical ventilation is not feasible or unavailable. In the prone position, the patient's face is facing the ground, the chest is sinking, and the abdomen is rising. This posture can improve alveolar ventilation and blood flow distribution, reduce pulmonary edema and pulmonary vascular resistance. In addition, the prone position can also improve the coordination of respiratory muscles, promote pulmonary expectoration, and increase functional residual capacity. Although the prone position has been widely used, there is still some controversy over when to use it. Some studies have shown that using the APP for early-stage COVID-19 patients can reduce mortality rates and respiratory dependence time, while others believe that using the APP in the later stages may increase the risk of lung injury. Therefore, it is necessary to further study when to use the APP and its impact on treatment effectiveness and safety. Such research may need to consider multiple factors, such as the patient's clinical symptoms, the severity of lung lesions, lung function indicators, and the duration of using the prone position. Determining the optimal time to use the APP will help guide clinical physicians to better apply this treatment strategy in the treatment of COVID-19 patients. In addition, the prone position can also be used in the treatment of other respiratory system diseases, so relevant research can also provide references and inspiration for the treatment of other diseases. The goal of this observational study is to learn about the details which might optimize the effect of APP in COVID-19 patients. The main questions it aims to answer are:

• The optimal time to start in the prone position
• the optimal duration of APP treatment
• the strategies to improve the tolerance of the awake prone position

Conditions

Coronavirus Pneumonia

Outcome Measures

Primary Outcomes (1)

• mortality rate

  hospital mortality

  From December 2022 to February 2023

Secondary Outcomes (1)

• Rate of adverse respiratory outcomes

  From December 2022 to February 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients admitted to two tertiary hospitals in Shanghai, China from December 2022 to February 2023

You may qualify if:

• age 18 years or older;
• laboratory-confirmed COVID-19 patients;
• radiographic evidence of pulmonary inflammation;
• clear consciousness and ability to communicate verbally;
• patients who have undergone prone position ventilation at least once during hospitalization;

You may not qualify if:

• Patients who were mechanically ventilated with oral intubation immediately after admission or 2 h after admission.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Zhang W, He Y, Gu Q, Zhang Y, Zha Q, Feng Q, Zhang S, He Y, Kang L, Xue M, Jing F, Li J, Mao Y, Zhu W. Optimal timing for awake prone positioning in Covid-19 patients: Insights from an observational study from two centers. Int J Nurs Stud. 2024 Apr;152:104707. doi: 10.1016/j.ijnurstu.2024.104707. Epub 2024 Feb 2.

  PMID: 38368846 DERIVED

Study Officials

• weiqing zhang, Ph.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 3, 2023
• Study Start: April 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-03

Locations

CN (1)