Influence of Early Standing Training on ICU Patients

Influence of early standing training on ICU patients

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease
• Intervention / Treatment: Behavioral: Intensive rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Ying; Phone Number: 17600953801 17600953801; Email: 1412888703@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Early standing training and routine rehabilitation	Behavioral: Intensive rehabilitation; Early standing training and routine rehabilitation
Active Comparator: control group; Conventional rehabilitation，Muscle training and breathing training	Behavioral: Intensive rehabilitation; Early standing training and routine rehabilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: xin li xie, The First Medical Center of PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Intensive rehabilitation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No