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Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Primary Purpose

Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary rehabilitation therapy
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%;
  • 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

    No Intervention

    Arm Label

    Experimental group

    Control group

    Arm Description

    Pulmonary rehabilitation therapy

    Routine medical treatment

    Outcomes

    Primary Outcome Measures

    MRC
    Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.
    STS
    Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
    barthel index
    barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.
    Borg dyspnea score
    Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
    PaO2
    arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
    Oxygenation index
    arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
    Diaphragm mobility
    The distance the diaphragm drops during inhalation,normal is 1.4cm.
    Diaphragm contraction velocity
    The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
    End-inspiratory diaphragm thickness
    The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
    End-expiratory diaphragm thickness
    The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
    Diaphragm thickness variation rate
    Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.

    Secondary Outcome Measures

    ICU stay time
    icu length of stay
    Hospitalization time
    Hospitalization time,length of stay in hospital.
    The time it takes to get out of bed for the first time
    The time it takes to get out of bed for the first time
    Use of non-invasive ventilator
    Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
    Intubation
    Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
    mortality
    mortality
    Complication
    The incidence of new complications(pressure sores、thrombus、aspiration).

    Full Information

    First Posted
    June 16, 2020
    Last Updated
    December 14, 2020
    Sponsor
    Chinese PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04441151
    Brief Title
    Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
    Official Title
    Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 20, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    June 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
    Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy
    Detailed Description
    Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.

    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
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Pulmonary rehabilitation therapy
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Routine medical treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pulmonary rehabilitation therapy
    Intervention Description
    Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.
    Primary Outcome Measure Information:
    Title
    MRC
    Description
    Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.
    Time Frame
    Day 28
    Title
    STS
    Description
    Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
    Time Frame
    Day 28
    Title
    barthel index
    Description
    barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.
    Time Frame
    Day 28
    Title
    Borg dyspnea score
    Description
    Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
    Time Frame
    Day 28
    Title
    PaO2
    Description
    arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
    Time Frame
    Day 28
    Title
    Oxygenation index
    Description
    arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
    Time Frame
    Day 28
    Title
    Diaphragm mobility
    Description
    The distance the diaphragm drops during inhalation,normal is 1.4cm.
    Time Frame
    Day 28
    Title
    Diaphragm contraction velocity
    Description
    The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
    Time Frame
    Day 28
    Title
    End-inspiratory diaphragm thickness
    Description
    The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
    Time Frame
    Day 28
    Title
    End-expiratory diaphragm thickness
    Description
    The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
    Time Frame
    Day 28
    Title
    Diaphragm thickness variation rate
    Description
    Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    ICU stay time
    Description
    icu length of stay
    Time Frame
    3 month
    Title
    Hospitalization time
    Description
    Hospitalization time,length of stay in hospital.
    Time Frame
    Month 3
    Title
    The time it takes to get out of bed for the first time
    Description
    The time it takes to get out of bed for the first time
    Time Frame
    Day 28
    Title
    Use of non-invasive ventilator
    Description
    Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
    Time Frame
    Day 28
    Title
    Intubation
    Description
    Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
    Time Frame
    Day 28
    Title
    mortality
    Description
    mortality
    Time Frame
    Day 28
    Title
    Complication
    Description
    The incidence of new complications(pressure sores、thrombus、aspiration).
    Time Frame
    Day 28

    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%; 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
    Zhao Ying
    Organizational Affiliation
    The First Medical Center of PLA General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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