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Effects of Standing at Different Angles on Transpulmonary Pressure

Primary Purpose

Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Change of standing Angle
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The age is ≥ 18 years old;
  • the hemodynamics is stable;
  • 50 < heart rate < 120 beats / min ;
  • 90 < systolic blood pressure < 200mmHg ;
  • 55 < mean arterial pressure < 120mmHg;
  • do not increase the dose of pressor drugs for at least 2 hours;
  • intracranial pressure is stable and there are no seizures within 24 hours;
  • the respiratory state is stable;
  • the patient's finger pulse oxygen saturation ≥ 88%;
  • 10 < respiratory frequency < 35 beats / min.

Exclusion Criteria:

  • Pregnancy;
  • acute cardio-cerebrovascular events;
  • spinal or limb fractures;
  • active bleeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Standing Angle

    Arm Description

    Assist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees

    Outcomes

    Primary Outcome Measures

    transpulmonary pressure
    End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
    Esophageal pressure
    The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
    Dead space rate
    the smaller,the better
    tidal volume
    Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
    partial pressure of carbon dioxide in endexpiratory gas
    The smaller the difference between pCO2 and arterial blood gas, the better

    Secondary Outcome Measures

    adverse reaction
    hypotension、Accident to take off the tube、Drop of bed,Record the number of times it happens.The more it happens, the less safe it is.

    Full Information

    First Posted
    June 26, 2020
    Last Updated
    July 1, 2020
    Sponsor
    Chinese PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04451421
    Brief Title
    Effects of Standing at Different Angles on Transpulmonary Pressure
    Official Title
    Effects of Standing at Different Angles on Transpulmonary Pressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese PLA General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Effects of standing at different angles on transpulmonary pressure
    Detailed Description
    Objective: To study the effect of different standing angles on cross-lung pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure across the lungs, and improve ventilation.Selection methods: patients with invasive mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of electric bed training in standing in different angles, start from 20 degrees, 5 degrees up every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure, die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and record whether low blood pressure, an accident in the process of take off the tube and other adverse reactions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standing Angle
    Arm Type
    Experimental
    Arm Description
    Assist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees
    Intervention Type
    Behavioral
    Intervention Name(s)
    Change of standing Angle
    Intervention Description
    Change the patient's standing Angle by using an electric bed
    Primary Outcome Measure Information:
    Title
    transpulmonary pressure
    Description
    End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
    Time Frame
    5 minutes
    Title
    Esophageal pressure
    Description
    The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
    Time Frame
    5 minutes
    Title
    Dead space rate
    Description
    the smaller,the better
    Time Frame
    5 minutes
    Title
    tidal volume
    Description
    Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
    Time Frame
    5 minutes
    Title
    partial pressure of carbon dioxide in endexpiratory gas
    Description
    The smaller the difference between pCO2 and arterial blood gas, the better
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    adverse reaction
    Description
    hypotension、Accident to take off the tube、Drop of bed,Record the number of times it happens.The more it happens, the less safe it is.
    Time Frame
    an hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The age is ≥ 18 years old; the hemodynamics is stable; 50 < heart rate < 120 beats / min ; 90 < systolic blood pressure < 200mmHg ; 55 < mean arterial pressure < 120mmHg; do not increase the dose of pressor drugs for at least 2 hours; intracranial pressure is stable and there are no seizures within 24 hours; the respiratory state is stable; the patient's finger pulse oxygen saturation ≥ 88%; 10 < respiratory frequency < 35 beats / min. Exclusion Criteria: Pregnancy; acute cardio-cerebrovascular events; spinal or limb fractures; active bleeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhao Ying
    Phone
    17600953801
    Ext
    17600953801
    Email
    1412888703@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    xin li xie, Ph.D.
    Organizational Affiliation
    The First Medical Center of PLA General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Standing at Different Angles on Transpulmonary Pressure

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