Clincosm LogoSign in Get a demo

Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05715788
Collaborator
(none)
30
Enrollment
1
Location
11.3
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitric oxide
  • Behavioral: prone positioning

Detailed Description

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prone Positioning Versus Prone Positioning and NO Inhalation in COVID-19 Associated Acute Respiratory Distress Syndrome.
Actual Study Start Date :
Dec 21, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
patients ventilated in prone position

Patients ventilated in prone position

Behavioral: prone positioning
vatilation in prone position
Other Names:
  • PPV

    		•
    Patients ventilated in prone position with NO inhalation

    Patients ventilated in prone position with NO inhalation

    Drug: Nitric oxide
    Nitric oxide inhalation at 20 ppm

    Behavioral: prone positioning
    vatilation in prone position
    Other Names:
  • PPV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. P/F ratio [16 hours]

      P/F ratios in each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients with COVID-19 associated ARDS
    Exclusion Criteria:
    • patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Study Chair: Ming Zhong, PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05715788
    Other Study ID Numbers:
    • ppv-vs-ppvno
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Syndrome
    Nitric Oxide

    Study Results

    No Results Posted as of Feb 8, 2023