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

NCT05570903 | Unknown

• 1 other identifier: luyuanqiang
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• Endotracheal intubation rate

  Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation

  28 days

• Mortality

  Death

  28 days

Secondary Outcomes (6)

• Total hours of prone position at day

  28 days

• Total number of prone sessions at day

  28 days

• Total days of prone positioning therapy

  28 days

• Non-invasive ventilation days

  28 days

• Change in the ROX-index 1-hour after first prone session

  1 hour

Study Arms (2)

Awake prone position Group

Patients in awake prone position will be included.

Non awake prone position Group

Patients in non awake prone position will be included.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute and critical patients transferred from primary hospitals or admitted to emergency departments

You may qualify if:

• 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 ;

You may not qualify if:

• 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)；

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: October 10, 2022
• Primary Completion: October 9, 2024
• Study Completion: September 9, 2025
• Last Updated: October 10, 2022

Record last verified: 2022-10