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Influence of Early Standing Training on ICU Patients

Influence of Early Standing Training on ICU Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04460391
Enrollment
50
Registered
2020-07-07
Start date
2020-10-01
Completion date
2021-10-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease

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.

Interventions

Early standing training and routine rehabilitation

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
icu length of staythree monthsicu length of stay
Time required for independent walkingthree monthsTime required for independent walking
delirium28 daysConfusion Assessment Method of the Intensive Care Unit. Positive is delirium.
mortality28 daysmortality
reintubation28 daysNote whether intubation was performed within 28 days.
Mechanical ventilation timethree monthsMechanical ventilation time

Contacts

Primary ContactZhao Ying
1412888703@qq.com17600953801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026