跳至主要内容
临床试验/NCT04460391
NCT04460391Unknown不适用

Influence of Early Standing Training on ICU Patients

Chinese PLA General Hospital0 个研究点目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Timed Inspiration

研究概览

简要总结

Influence of early standing training on ICU patients

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

control group

Active Comparator

Conventional rehabilitation,Muscle training and breathing training

干预措施: Intensive rehabilitation (Behavioral)

experimental group

Experimental

Early standing training and routine rehabilitation

干预措施: Intensive rehabilitation (Behavioral)

结局指标

主要结局

Timed Inspiration

时间窗: day 14

Normal adults are 1s

Medical Research Council

时间窗: day 14

Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.

Berg Balance Scale

时间窗: day 14

Balance grade score,The highest 56 points,The higher the score, the better the balance.

FIM Function Independent Scale

时间窗: day 14

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

时间窗: day 14

Levels 0 to 5,The higher the grade, the better the ability to walk

arterial blood gas analysis

时间窗: day 14

PH,normal range 7.35-7.45

partial pressure of carbon dioxide

时间窗: day 14

normal range 35-45 mmHg

oxygenation index

时间窗: day 14

Normal adults are 400,the higher,the better

lactic acid

时间窗: day 14

normal range 0.5-1.6mmol/L

Diaphragmatic movement

时间窗: day 14

The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

Diaphragm contraction rate

时间窗: day 14

Normal adults are 1.3cm/s

Diaphragm thickness at end of breath

时间窗: day 14

Normal adults are 0.15cm

Diaphragm thickness at end of inhalation

时间窗: day 14

Normal adults are 0.28cm

Diaphragmatic thickness variation rate

时间窗: day 14

Less than 20% have diaphragmatic dysfunction

E-T index

时间窗: day 14

Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

Rectus femoris thickness

时间窗: day 14

The thicker the muscle, the better

Thickness of tibialis anterior muscle

时间窗: day 14

The thicker the muscle, the better

partial pressure of carbon dioxide

时间窗: day 7

normal range 35-45 mmHg

Berg Balance Scale

时间窗: day 1

Balance grade score,The highest 56 points,The higher the score, the better the balance.

Berg Balance Scale

时间窗: day 7

Balance grade score,The highest 56 points,The higher the score, the better the balance.

arterial blood gas analysis

时间窗: day 7

PH,normal range 7.35-7.45

Medical Research Council

时间窗: day 1

Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.

Medical Research Council

时间窗: day 7

Muscle strength assessment of ICU patients,Out of 60 points,Less than 48 points had acquired muscle weakness in the ICU.

FIM Function Independent Scale

时间窗: day 1

Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.

oxygenation index

时间窗: day 1

Normal adults are 400,the higher,the better

FIM Function Independent Scale

时间窗: day 7

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

时间窗: day 1

Levels 0 to 5,The higher the grade, the better the ability to walk

Holden walk classification

时间窗: day 7

Levels 0 to 5,The higher the grade, the better the ability to walk

arterial blood gas analysis

时间窗: day 1

PH,normal range 7.35-7.45

partial pressure of carbon dioxide

时间窗: day 1

normal range 35-45 mmHg

oxygenation index

时间窗: day 7

Normal adults are 400,the higher,the better

lactic acid

时间窗: day 1

normal range 0.5-1.6mmol/L

lactic acid

时间窗: day 7

normal range 0.5-1.6mmol/L

Diaphragmatic movement

时间窗: day 1

The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

Diaphragmatic movement

时间窗: day 7

The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

Diaphragm contraction rate

时间窗: day 1

Normal adults are 1.3cm/s

Diaphragm contraction rate

时间窗: day 7

Normal adults are 1.3cm/s

Diaphragm thickness at end of breath

时间窗: day 1

Normal adults are 0.15cm

Diaphragm thickness at end of breath

时间窗: day 7

Normal adults are 0.15cm

Diaphragm thickness at end of inhalation

时间窗: day 1

Normal adults are 0.28cm

Diaphragm thickness at end of inhalation

时间窗: day 7

Normal adults are 0.28cm

Diaphragmatic thickness variation rate

时间窗: day 1

Less than 20% have diaphragmatic dysfunction

Diaphragmatic thickness variation rate

时间窗: day 7

Less than 20% have diaphragmatic dysfunction

E-T index

时间窗: day 1

Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

E-T index

时间窗: day 7

Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

Timed Inspiration

时间窗: day 1

Normal adults are 1s

Timed Inspiration

时间窗: day 7

Normal adults are 1s

Rectus femoris thickness

时间窗: day 1

The thicker the muscle, the better

Rectus femoris thickness

时间窗: day 7

The thicker the muscle, the better

Thickness of tibialis anterior muscle

时间窗: day 1

The thicker the muscle, the better

Thickness of tibialis anterior muscle

时间窗: day 7

The thicker the muscle, the better

次要结局

  • delirium(28 days)
  • mortality(28 days)
  • reintubation(28 days)
  • Mechanical ventilation time(three months)
  • icu length of stay(three months)
  • Time required for independent walking(three months)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

wang kaifei

Ph.D.

Chinese PLA General Hospital

相似试验