Clinical trial NCT04460391: Influence of Early Standing Training on ICU Patients
Official title: Influence of Early Standing Training on ICU Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Medical Research Council
timeFrame: day 1
measure: Medical Research Council
timeFrame: day 7
measure: Medical Research Council
timeFrame: day 14
measure: Berg Balance Scale
timeFrame: day 1
measure: Berg Balance Scale
timeFrame: day 7
measure: Berg Balance Scale
timeFrame: day 14
measure: FIM Function Independent Scale
timeFrame: day 1
measure: FIM Function Independent Scale
timeFrame: day 7
measure: FIM Function Independent Scale
timeFrame: day 14
measure: Holden walk classification
timeFrame: day 1
measure: Holden walk classification
timeFrame: day 7
measure: Holden walk classification
timeFrame: day 14
measure: arterial blood gas analysis
timeFrame: day 1
measure: arterial blood gas analysis
timeFrame: day 7
measure: arterial blood gas analysis
timeFrame: day 14
measure: partial pressure of carbon dioxide
timeFrame: day 1
measure: partial pressure of carbon dioxide
timeFrame: day 7
measure: partial pressure of carbon dioxide
timeFrame: day 14
measure: oxygenation index
timeFrame: day 1
measure: oxygenation index
timeFrame: day 7
measure: oxygenation index
timeFrame: day 14
measure: lactic acid
timeFrame: day 1
measure: lactic acid
timeFrame: day 7
measure: lactic acid
timeFrame: day 14
measure: Diaphragmatic movement
timeFrame: day 1
measure: Diaphragmatic movement
timeFrame: day 7
measure: Diaphragmatic movement
timeFrame: day 14
measure: Diaphragm contraction rate
timeFrame: day 1
measure: Diaphragm contraction rate
timeFrame: day 7
measure: Diaphragm contraction rate
timeFrame: day 14
measure: Diaphragm thickness at end of breath
timeFrame: day 1
measure: Diaphragm thickness at end of breath
timeFrame: day 7
measure: Diaphragm thickness at end of breath
timeFrame: day 14
measure: Diaphragm thickness at end of inhalation
timeFrame: day 1
measure: Diaphragm thickness at end of inhalation
timeFrame: day 7
measure: Diaphragm thickness at end of inhalation
timeFrame: day 14
measure: Diaphragmatic thickness variation rate
timeFrame: day 1
measure: Diaphragmatic thickness variation rate
timeFrame: day 7
measure: Diaphragmatic thickness variation rate
timeFrame: day 14
measure: E-T index
timeFrame: day 1
measure: E-T index
timeFrame: day 7
measure: E-T index
timeFrame: day 14
measure: Timed Inspiration
timeFrame: day 1
measure: Timed Inspiration
timeFrame: day 7
measure: Timed Inspiration
timeFrame: day 14
measure: Rectus femoris thickness
timeFrame: day 1
measure: Rectus femoris thickness
timeFrame: day 7
measure: Rectus femoris thickness
timeFrame: day 14
measure: Thickness of tibialis anterior muscle
timeFrame: day 1
measure: Thickness of tibialis anterior muscle
timeFrame: day 7
measure: Thickness of tibialis anterior muscle
timeFrame: day 14
Secondary outcomes:
measure: Mechanical ventilation time
timeFrame: three months
measure: icu length of stay
timeFrame: three months
measure: Time required for independent walking
timeFrame: three months
measure: delirium
timeFrame: 28 days
measure: mortality
timeFrame: 28 days
measure: reintubation
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: The First Medical Center of PLA General Hospital
name: xin li xie
role: PRINCIPAL_INVESTIGATOR
References: