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Influence of Early Standing Training on ICU Patients

Primary Purpose

Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive rehabilitation
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 - 100 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%;
  • Oxygen concentration less than 60%;
  • Terminal positive expiratory pressure<12cmH2O;
  • 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 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    Early standing training and routine rehabilitation

    Conventional rehabilitation,Muscle training and breathing training

    Outcomes

    Primary Outcome Measures

    Medical Research Council
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Medical Research Council
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Medical Research Council
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Berg Balance Scale
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    Berg Balance Scale
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    Berg Balance Scale
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    FIM Function Independent Scale
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    FIM Function Independent Scale
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    FIM Function Independent Scale
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    Holden walk classification
    Levels 0 to 5,The higher the grade, the better the ability to walk
    Holden walk classification
    Levels 0 to 5,The higher the grade, the better the ability to walk
    Holden walk classification
    Levels 0 to 5,The higher the grade, the better the ability to walk
    arterial blood gas analysis
    PH,normal range 7.35-7.45
    arterial blood gas analysis
    PH,normal range 7.35-7.45
    arterial blood gas analysis
    PH,normal range 7.35-7.45
    partial pressure of carbon dioxide
    normal range 35-45 mmHg
    partial pressure of carbon dioxide
    normal range 35-45 mmHg
    partial pressure of carbon dioxide
    normal range 35-45 mmHg
    oxygenation index
    Normal adults are 400,the higher,the better
    oxygenation index
    Normal adults are 400,the higher,the better
    oxygenation index
    Normal adults are 400,the higher,the better
    lactic acid
    normal range 0.5-1.6mmol/L
    lactic acid
    normal range 0.5-1.6mmol/L
    lactic acid
    normal range 0.5-1.6mmol/L
    Diaphragmatic movement
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Diaphragmatic movement
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Diaphragmatic movement
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Diaphragm contraction rate
    Normal adults are 1.3cm/s
    Diaphragm contraction rate
    Normal adults are 1.3cm/s
    Diaphragm contraction rate
    Normal adults are 1.3cm/s
    Diaphragm thickness at end of breath
    Normal adults are 0.15cm
    Diaphragm thickness at end of breath
    Normal adults are 0.15cm
    Diaphragm thickness at end of breath
    Normal adults are 0.15cm
    Diaphragm thickness at end of inhalation
    Normal adults are 0.28cm
    Diaphragm thickness at end of inhalation
    Normal adults are 0.28cm
    Diaphragm thickness at end of inhalation
    Normal adults are 0.28cm
    Diaphragmatic thickness variation rate
    Less than 20% have diaphragmatic dysfunction
    Diaphragmatic thickness variation rate
    Less than 20% have diaphragmatic dysfunction
    Diaphragmatic thickness variation rate
    Less than 20% have diaphragmatic dysfunction
    E-T index
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    E-T index
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    E-T index
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    Timed Inspiration
    Normal adults are 1s
    Timed Inspiration
    Normal adults are 1s
    Timed Inspiration
    Normal adults are 1s
    Rectus femoris thickness
    The thicker the muscle, the better
    Rectus femoris thickness
    The thicker the muscle, the better
    Rectus femoris thickness
    The thicker the muscle, the better
    Thickness of tibialis anterior muscle
    The thicker the muscle, the better
    Thickness of tibialis anterior muscle
    The thicker the muscle, the better
    Thickness of tibialis anterior muscle
    The thicker the muscle, the better

    Secondary Outcome Measures

    Mechanical ventilation time
    Mechanical ventilation time
    icu length of stay
    icu length of stay
    Time required for independent walking
    Time required for independent walking
    delirium
    Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.
    mortality
    mortality
    reintubation
    Note whether intubation was performed within 28 days.

    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
    NCT04460391
    Brief Title
    Influence of Early Standing Training on ICU Patients
    Official Title
    Influence of Early Standing Training on ICU Patients
    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
    Influence of early standing training on ICU patients
    Detailed Description
    Objective: To study the effect of early standing training on ICU patients.Background: Early severe rehabilitation is of great significance for patients, which can help patients withdraw from mechanical ventilation as soon as possible, improve pulmonary ventilation, and promote early walking.However, patients on mechanical ventilation are more prone to delirium, muscle weakness, ventilator dependence and other problems. Early standing training can significantly improve patients' lower limb muscle strength, improve diaphragm function, improve the prognosis of patients, and reduce the length of hospital stay.Methods: selecting stable hemodynamics in ICU patients with mechanical ventilation, randomly divided into two groups, a group of routine rehabilitation training, another group stand for regular rehabilitation and early training, with the aid of electric beds, on the first day of patients, to evaluate the seventh day, the 14th day, and collect the basic information for patients and strength assessment, blood gas analysis, the diaphragm of the bed and ultrasound and muscle ultrasound, and record the patient's mortality within 28 days, the incidence of delirium, decannulation rate, etc., recorded in patients with mechanical ventilation time and the time required to walk independently and ICU stay time.

    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
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Early standing training and routine rehabilitation
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Conventional rehabilitation,Muscle training and breathing training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive rehabilitation
    Intervention Description
    Early standing training and routine rehabilitation
    Primary Outcome Measure Information:
    Title
    Medical Research Council
    Description
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Time Frame
    day 1
    Title
    Medical Research Council
    Description
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Time Frame
    day 7
    Title
    Medical Research Council
    Description
    Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.
    Time Frame
    day 14
    Title
    Berg Balance Scale
    Description
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    Time Frame
    day 1
    Title
    Berg Balance Scale
    Description
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    Time Frame
    day 7
    Title
    Berg Balance Scale
    Description
    Balance grade score,The highest 56 points,The higher the score, the better the balance.
    Time Frame
    day 14
    Title
    FIM Function Independent Scale
    Description
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    Time Frame
    day 1
    Title
    FIM Function Independent Scale
    Description
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    Time Frame
    day 7
    Title
    FIM Function Independent Scale
    Description
    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
    Time Frame
    day 14
    Title
    Holden walk classification
    Description
    Levels 0 to 5,The higher the grade, the better the ability to walk
    Time Frame
    day 1
    Title
    Holden walk classification
    Description
    Levels 0 to 5,The higher the grade, the better the ability to walk
    Time Frame
    day 7
    Title
    Holden walk classification
    Description
    Levels 0 to 5,The higher the grade, the better the ability to walk
    Time Frame
    day 14
    Title
    arterial blood gas analysis
    Description
    PH,normal range 7.35-7.45
    Time Frame
    day 1
    Title
    arterial blood gas analysis
    Description
    PH,normal range 7.35-7.45
    Time Frame
    day 7
    Title
    arterial blood gas analysis
    Description
    PH,normal range 7.35-7.45
    Time Frame
    day 14
    Title
    partial pressure of carbon dioxide
    Description
    normal range 35-45 mmHg
    Time Frame
    day 1
    Title
    partial pressure of carbon dioxide
    Description
    normal range 35-45 mmHg
    Time Frame
    day 7
    Title
    partial pressure of carbon dioxide
    Description
    normal range 35-45 mmHg
    Time Frame
    day 14
    Title
    oxygenation index
    Description
    Normal adults are 400,the higher,the better
    Time Frame
    day 1
    Title
    oxygenation index
    Description
    Normal adults are 400,the higher,the better
    Time Frame
    day 7
    Title
    oxygenation index
    Description
    Normal adults are 400,the higher,the better
    Time Frame
    day 14
    Title
    lactic acid
    Description
    normal range 0.5-1.6mmol/L
    Time Frame
    day 1
    Title
    lactic acid
    Description
    normal range 0.5-1.6mmol/L
    Time Frame
    day 7
    Title
    lactic acid
    Description
    normal range 0.5-1.6mmol/L
    Time Frame
    day 14
    Title
    Diaphragmatic movement
    Description
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Time Frame
    day 1
    Title
    Diaphragmatic movement
    Description
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Time Frame
    day 7
    Title
    Diaphragmatic movement
    Description
    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
    Time Frame
    day 14
    Title
    Diaphragm contraction rate
    Description
    Normal adults are 1.3cm/s
    Time Frame
    day 1
    Title
    Diaphragm contraction rate
    Description
    Normal adults are 1.3cm/s
    Time Frame
    day 7
    Title
    Diaphragm contraction rate
    Description
    Normal adults are 1.3cm/s
    Time Frame
    day 14
    Title
    Diaphragm thickness at end of breath
    Description
    Normal adults are 0.15cm
    Time Frame
    day 1
    Title
    Diaphragm thickness at end of breath
    Description
    Normal adults are 0.15cm
    Time Frame
    day 7
    Title
    Diaphragm thickness at end of breath
    Description
    Normal adults are 0.15cm
    Time Frame
    day 14
    Title
    Diaphragm thickness at end of inhalation
    Description
    Normal adults are 0.28cm
    Time Frame
    day 1
    Title
    Diaphragm thickness at end of inhalation
    Description
    Normal adults are 0.28cm
    Time Frame
    day 7
    Title
    Diaphragm thickness at end of inhalation
    Description
    Normal adults are 0.28cm
    Time Frame
    day 14
    Title
    Diaphragmatic thickness variation rate
    Description
    Less than 20% have diaphragmatic dysfunction
    Time Frame
    day 1
    Title
    Diaphragmatic thickness variation rate
    Description
    Less than 20% have diaphragmatic dysfunction
    Time Frame
    day 7
    Title
    Diaphragmatic thickness variation rate
    Description
    Less than 20% have diaphragmatic dysfunction
    Time Frame
    day 14
    Title
    E-T index
    Description
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    Time Frame
    day 1
    Title
    E-T index
    Description
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    Time Frame
    day 7
    Title
    E-T index
    Description
    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
    Time Frame
    day 14
    Title
    Timed Inspiration
    Description
    Normal adults are 1s
    Time Frame
    day 1
    Title
    Timed Inspiration
    Description
    Normal adults are 1s
    Time Frame
    day 7
    Title
    Timed Inspiration
    Description
    Normal adults are 1s
    Time Frame
    day 14
    Title
    Rectus femoris thickness
    Description
    The thicker the muscle, the better
    Time Frame
    day 1
    Title
    Rectus femoris thickness
    Description
    The thicker the muscle, the better
    Time Frame
    day 7
    Title
    Rectus femoris thickness
    Description
    The thicker the muscle, the better
    Time Frame
    day 14
    Title
    Thickness of tibialis anterior muscle
    Description
    The thicker the muscle, the better
    Time Frame
    day 1
    Title
    Thickness of tibialis anterior muscle
    Description
    The thicker the muscle, the better
    Time Frame
    day 7
    Title
    Thickness of tibialis anterior muscle
    Description
    The thicker the muscle, the better
    Time Frame
    day 14
    Secondary Outcome Measure Information:
    Title
    Mechanical ventilation time
    Description
    Mechanical ventilation time
    Time Frame
    three months
    Title
    icu length of stay
    Description
    icu length of stay
    Time Frame
    three months
    Title
    Time required for independent walking
    Description
    Time required for independent walking
    Time Frame
    three months
    Title
    delirium
    Description
    Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.
    Time Frame
    28 days
    Title
    mortality
    Description
    mortality
    Time Frame
    28 days
    Title
    reintubation
    Description
    Note whether intubation was performed within 28 days.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 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%; Oxygen concentration less than 60%; Terminal positive expiratory pressure<12cmH2O; 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
    Organizational Affiliation
    The First Medical Center of PLA General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Influence of Early Standing Training on ICU Patients

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