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
About this trial
This is an interventional treatment trial for Pulmonary Disease
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.
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
NCT ID
NCT04460391
First Posted
June 26, 2020
Last Updated
July 1, 2020
Sponsor
Chinese PLA General Hospital
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
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Influence of Early Standing Training on ICU Patients
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