A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure

Not yet recruiting

• Conditions: Acute Respiratory Failure

• Registration Number: NCT05570903
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Awake prone positioning has been used widely for patients with COVID-19.Many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with SARS-CoV-2 infected who are not intubated.The investigators will conduct a prospective observational study on patients with acute respiratory failure induced by various causes to determine whether awake prone position can reduce the need to upgrade to invasive mechanical ventilation and improve the prognosis of patients compared with standard treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-07
• Study Start: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2024-10-09
• Study Completion: 2025-09-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1.Older than 17 years, admitted to the ICU;2.Patients with acute respiratory failure meet the following conditions：①Under the condition of breathing air at rest, PaO2 of subjects is lower than 60mmHg and/or PaCO2 is higher than 50mmHg; ②Under the support of COT and HFNC, PaO2/FiO2 of the subject is less than 250; ③ Under the support of NIV ;

Exclusion Criteria

• 1.Refusing to cooperate with active treatment; 2.Immediate need for intubation as determined by the treating team.3Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)；4.Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury)；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endotracheal intubation rate	28 days	Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation
Mortality	28 days	Death

Secondary Outcome Measures

Name	Time	Method
Non-invasive ventilation days	28 days	Number of days not receiving non-invasive mechanical ventilation
Total length of stay in ICU and hospital	28 days	Total length of stay in ICU and hospital
Total days of prone positioning therapy	28 days	Total days of prone positioning therapy
Total number of prone sessions at day	28 days	Total number of prone sessions at day
Total hours of prone position at day	28 days	Total hours of prone position at day
Change in the ROX-index 1-hour after first prone session	1 hour	The change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index)