Influence of Early Standing Training on ICU Patients

Pulmonary Disease Clinical Trial

Official title:

Influence of Early Standing Training on ICU Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04460391
• Other study ID #: Intensive rehabilitation
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: June 2020
• Source: Chinese PLA General Hospital
• Contact: Zhao Ying
• Phone: 17600953801
• Email: 1412888703[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Influence of early standing training on ICU patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Behavioral:
• Intensive rehabilitation
Early standing training and routine rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Berg Balance Scale	Balance grade score,The highest 56 points,The higher the score, the better the balance.	day 1
Primary	Berg Balance Scale	Balance grade score,The highest 56 points,The higher the score, the better the balance.	day 7
Primary	Berg Balance Scale	Balance grade score,The highest 56 points,The higher the score, the better the balance.	day 14
Primary	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
Primary	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
Primary	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
Primary	Holden walk classification	Levels 0 to 5,The higher the grade, the better the ability to walk	day 1
Primary	Holden walk classification	Levels 0 to 5,The higher the grade, the better the ability to walk	day 7
Primary	Holden walk classification	Levels 0 to 5,The higher the grade, the better the ability to walk	day 14
Primary	arterial blood gas analysis	PH,normal range 7.35-7.45	day 1
Primary	arterial blood gas analysis	PH,normal range 7.35-7.45	day 7
Primary	arterial blood gas analysis	PH,normal range 7.35-7.45	day 14
Primary	partial pressure of carbon dioxide	normal range 35-45 mmHg	day 1
Primary	partial pressure of carbon dioxide	normal range 35-45 mmHg	day 7
Primary	partial pressure of carbon dioxide	normal range 35-45 mmHg	day 14
Primary	oxygenation index	Normal adults are 400,the higher,the better	day 1
Primary	oxygenation index	Normal adults are 400,the higher,the better	day 7
Primary	oxygenation index	Normal adults are 400,the higher,the better	day 14
Primary	lactic acid	normal range 0.5-1.6mmol/L	day 1
Primary	lactic acid	normal range 0.5-1.6mmol/L	day 7
Primary	lactic acid	normal range 0.5-1.6mmol/L	day 14
Primary	Diaphragmatic movement	The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.	day 1
Primary	Diaphragmatic movement	The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.	day 7
Primary	Diaphragmatic movement	The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.	day 14
Primary	Diaphragm contraction rate	Normal adults are 1.3cm/s	day 1
Primary	Diaphragm contraction rate	Normal adults are 1.3cm/s	day 7
Primary	Diaphragm contraction rate	Normal adults are 1.3cm/s	day 14
Primary	Diaphragm thickness at end of breath	Normal adults are 0.15cm	day 1
Primary	Diaphragm thickness at end of breath	Normal adults are 0.15cm	day 7
Primary	Diaphragm thickness at end of breath	Normal adults are 0.15cm	day 14
Primary	Diaphragm thickness at end of inhalation	Normal adults are 0.28cm	day 1
Primary	Diaphragm thickness at end of inhalation	Normal adults are 0.28cm	day 7
Primary	Diaphragm thickness at end of inhalation	Normal adults are 0.28cm	day 14
Primary	Diaphragmatic thickness variation rate	Less than 20% have diaphragmatic dysfunction	day 1
Primary	Diaphragmatic thickness variation rate	Less than 20% have diaphragmatic dysfunction	day 7
Primary	Diaphragmatic thickness variation rate	Less than 20% have diaphragmatic dysfunction	day 14
Primary	E-T index	Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.	day 1
Primary	E-T index	Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.	day 7
Primary	E-T index	Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.	day 14
Primary	Timed Inspiration	Normal adults are 1s	day 1
Primary	Timed Inspiration	Normal adults are 1s	day 7
Primary	Timed Inspiration	Normal adults are 1s	day 14
Primary	Rectus femoris thickness	The thicker the muscle, the better	day 1
Primary	Rectus femoris thickness	The thicker the muscle, the better	day 7
Primary	Rectus femoris thickness	The thicker the muscle, the better	day 14
Primary	Thickness of tibialis anterior muscle	The thicker the muscle, the better	day 1
Primary	Thickness of tibialis anterior muscle	The thicker the muscle, the better	day 7
Primary	Thickness of tibialis anterior muscle	The thicker the muscle, the better	day 14
Secondary	Mechanical ventilation time	Mechanical ventilation time	three months
Secondary	icu length of stay	icu length of stay	three months
Secondary	Time required for independent walking	Time required for independent walking	three months
Secondary	delirium	Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.	28 days
Secondary	mortality	mortality	28 days
Secondary	reintubation	Note whether intubation was performed within 28 days.	28 days