Influence of Early Standing Training on ICU Patients

Study Overview
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Brief Summary
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Influence of early standing training on ICU patients

Detailed Description
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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.

Official Title
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Influence of Early Standing Training on ICU Patients

Conditions
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Pulmonary Disease

Intervention / Treatment
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* Behavioral: Intensive rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Early standing training and routine rehabilitation | Behavioral: Intensive rehabilitation<br>* Early standing training and routine rehabilitation<br>|
| Active Comparator: control group<br>Conventional rehabilitation，Muscle training and breathing training | Behavioral: Intensive rehabilitation<br>* Early standing training and routine rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Research Council | Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU. | day 1 | 
| Medical Research Council | Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU. | day 7 | 
| Medical Research Council | Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU. | day 14 | 
| Berg Balance Scale | Balance grade score,The highest 56 points,The higher the score, the better the balance. | day 1 | 
| Berg Balance Scale | Balance grade score,The highest 56 points,The higher the score, the better the balance. | day 7 | 
| Berg Balance Scale | Balance grade score,The highest 56 points,The higher the score, the better the balance. | day 14 | 
| 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. | day 1 | 
| 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. | day 7 | 
| 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. | day 14 | 
| Holden walk classification | Levels 0 to 5,The higher the grade, the better the ability to walk | day 1 | 
| Holden walk classification | Levels 0 to 5,The higher the grade, the better the ability to walk | day 7 | 
| Holden walk classification | Levels 0 to 5,The higher the grade, the better the ability to walk | day 14 | 
| arterial blood gas analysis | PH,normal range 7.35-7.45 | day 1 | 
| arterial blood gas analysis | PH,normal range 7.35-7.45 | day 7 | 
| arterial blood gas analysis | PH,normal range 7.35-7.45 | day 14 | 
| partial pressure of carbon dioxide | normal range 35-45 mmHg | day 1 | 
| partial pressure of carbon dioxide | normal range 35-45 mmHg | day 7 | 
| partial pressure of carbon dioxide | normal range 35-45 mmHg | day 14 | 
| oxygenation index | Normal adults are 400,the higher，the better | day 1 | 
| oxygenation index | Normal adults are 400,the higher，the better | day 7 | 
| oxygenation index | Normal adults are 400,the higher，the better | day 14 | 
| lactic acid | normal range 0.5-1.6mmol/L | day 1 | 
| lactic acid | normal range 0.5-1.6mmol/L | day 7 | 
| lactic acid | normal range 0.5-1.6mmol/L | day 14 | 
| Diaphragmatic movement | The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm. | day 1 | 
| Diaphragmatic movement | The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm. | day 7 | 
| Diaphragmatic movement | The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm. | day 14 | 
| Diaphragm contraction rate | Normal adults are 1.3cm/s | day 1 | 
| Diaphragm contraction rate | Normal adults are 1.3cm/s | day 7 | 
| Diaphragm contraction rate | Normal adults are 1.3cm/s | day 14 | 
| Diaphragm thickness at end of breath | Normal adults are 0.15cm | day 1 | 
| Diaphragm thickness at end of breath | Normal adults are 0.15cm | day 7 | 
| Diaphragm thickness at end of breath | Normal adults are 0.15cm | day 14 | 
| Diaphragm thickness at end of inhalation | Normal adults are 0.28cm | day 1 | 
| Diaphragm thickness at end of inhalation | Normal adults are 0.28cm | day 7 | 
| Diaphragm thickness at end of inhalation | Normal adults are 0.28cm | day 14 | 
| Diaphragmatic thickness variation rate | Less than 20% have diaphragmatic dysfunction | day 1 | 
| Diaphragmatic thickness variation rate | Less than 20% have diaphragmatic dysfunction | day 7 | 
| Diaphragmatic thickness variation rate | Less than 20% have diaphragmatic dysfunction | day 14 | 
| E-T index | Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate. | day 1 | 
| E-T index | Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate. | day 7 | 
| E-T index | Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate. | day 14 | 
| Timed Inspiration | Normal adults are 1s | day 1 | 
| Timed Inspiration | Normal adults are 1s | day 7 | 
| Timed Inspiration | Normal adults are 1s | day 14 | 
| Rectus femoris thickness | The thicker the muscle, the better | day 1 | 
| Rectus femoris thickness | The thicker the muscle, the better | day 7 | 
| Rectus femoris thickness | The thicker the muscle, the better | day 14 | 
| Thickness of tibialis anterior muscle | The thicker the muscle, the better | day 1 | 
| Thickness of tibialis anterior muscle | The thicker the muscle, the better | day 7 | 
| Thickness of tibialis anterior muscle | The thicker the muscle, the better | day 14 | 

Secondary Outcome Measures

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