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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05570903
• Other study ID #: luyuanqiang
• Status: Not yet recruiting
• Start date: October 10, 2022
• Est. completion date: September 9, 2025

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 9, 2025
• Est. primary completion date: October 9, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotracheal intubation rate	Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation	28 days
Primary	Mortality	Death	28 days
Secondary	Total hours of prone position at day	Total hours of prone position at day	28 days
Secondary	Total number of prone sessions at day	Total number of prone sessions at day	28 days
Secondary	Total days of prone positioning therapy	Total days of prone positioning therapy	28 days
Secondary	Non-invasive ventilation days	Number of days not receiving non-invasive mechanical ventilation	28 days
Secondary	Change in the ROX-index 1-hour after first prone session	The change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index)	1 hour
Secondary	Total length of stay in ICU and hospital	Total length of stay in ICU and hospital	28 days