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

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05570903
Collaborator
(none)
120
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure
    Anticipated Study Start Date :
    Oct 10, 2022
    Anticipated Primary Completion Date :
    Oct 9, 2024
    Anticipated Study Completion Date :
    Sep 9, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Endotracheal intubation rate [28 days]

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

    2. Mortality [28 days]

      Death

    Secondary Outcome Measures

    1. Total hours of prone position at day [28 days]

      Total hours of prone position at day

    2. Total number of prone sessions at day [28 days]

      Total number of prone sessions at day

    3. Total days of prone positioning therapy [28 days]

      Total days of prone positioning therapy

    4. Non-invasive ventilation days [28 days]

      Number of days not receiving non-invasive mechanical ventilation

    5. 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)

    6. Total length of stay in ICU and hospital [28 days]

      Total length of stay in ICU and hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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);

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuan-Qiang Lu, Professor, First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05570903
    Other Study ID Numbers:
    • luyuanqiang
    First Posted:
    Oct 7, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2022