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Status unknownNCT05570903Updated Oct 10, 2022

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

An observational study in Acute Respiratory Failure, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Respiratory Failure
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In context

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 260 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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);
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Endotracheal intubation rate

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

    Time frame: 28 days

  2. Mortality

    Death

    Time frame: 28 days

Secondary outcomes

  1. Total hours of prone position at day

    Total hours of prone position at day

    Time frame: 28 days

  2. Total number of prone sessions at day

    Total number of prone sessions at day

    Time frame: 28 days

  3. Total days of prone positioning therapy

    Total days of prone positioning therapy

    Time frame: 28 days

  4. Non-invasive ventilation days

    Number of days not receiving non-invasive mechanical ventilation

    Time frame: 28 days

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

    The change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index)

    Time frame: 1 hour

  6. Total length of stay in ICU and hospital

    Total length of stay in ICU and hospital

    Time frame: 28 days

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05570903
Responsible party
Yuan-Qiang Lu (Professor, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Oct 7, 2022
Start date
Oct 10, 2022 (estimated)
Primary completion
Oct 9, 2024 (estimated)
Completion
Sep 9, 2025 (estimated)
Last update
Oct 10, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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