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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05570903
Enrollment
120
Registered
2022-10-07
Start date
2022-10-10
Completion date
2025-09-09
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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);

Design outcomes

Primary

MeasureTime frameDescription
Endotracheal intubation rate28 daysPercentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation
Mortality28 daysDeath

Secondary

MeasureTime frameDescription
Total days of prone positioning therapy28 daysTotal days of prone positioning therapy
Non-invasive ventilation days28 daysNumber of days not receiving non-invasive mechanical ventilation
Total hours of prone position at day28 daysTotal hours of prone position at day
Total length of stay in ICU and hospital28 daysTotal length of stay in ICU and hospital
Change in the ROX-index 1-hour after first prone session1 hourThe change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index)
Total number of prone sessions at day28 daysTotal number of prone sessions at day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026