Influence of Early Standing Training on ICU Patients

NCT04460391 | Unknown

• 1 other identifier: Intensive rehabilitation
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Influence of early standing training on ICU patients

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (51)

• 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 Outcomes (6)

• Mechanical ventilation time

  three months

• icu length of stay

  three months

• Time required for independent walking

  three months

• delirium

  28 days

• mortality

  28 days

Study Arms (2)

experimental group

EXPERIMENTAL

Early standing training and routine rehabilitation

Behavioral: Intensive rehabilitation

control group

ACTIVE COMPARATOR

Conventional rehabilitation，Muscle training and breathing training

Behavioral: Intensive rehabilitation

Interventions

Intensive rehabilitation BEHAVIORAL

Early standing training and routine rehabilitation

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is ≥ 18 years old;
• the hemodynamics is stable;
• \< heart rate \< 120 beats / min ;
• \< systolic blood pressure \< 200mmHg ;
• \< 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；
• \< respiratory frequency \< 35 beats / min.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• xin li xie

  The First Medical Center of PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Ying

CONTACT

17600953801; 1412888703@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-06