Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Respiratory Rehabilitation on ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368286
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
wang kaifei, Chinese PLA General Hospital

Brief Summary:
Effects of respiratory rehabilitation on patients after extubation

Condition or disease Intervention/treatment Phase
ICU Acquired Weakness Rehabilitation Behavioral: pulmonary rehabilitation Not Applicable

Detailed Description:
The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 < heart rate less than 120 beats/min, 90 < systolic blood pressure < 200mmHg, 55 < mean arterial pressure < 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was >10 and< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P < 0.05 was considered significant.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Respiratory Rehabilitation on Patients After Extubation
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : October 10, 2020
Actual Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rehabilitation group
To conduct a comprehensive pulmonary rehabilitation assessment and treatment
Behavioral: pulmonary rehabilitation
Pulmonary rehabilitation (respiratory rehabilitation) is a comprehensive intervention based on a comprehensive patient assessment, targeted to the treatment of patients, including but not limited to exercise training, education and behavior change, aimed at improving the physical and mental health of patients with chronic respiratory diseases and promoting long-term adherence to health-enhancing behaviors.

No Intervention: Conventional medical group
Conventional medical treatment



Primary Outcome Measures :
  1. Reintubation rates [ Time Frame: 28 days ]
    The artificial airway was established again for invasive mechanical ventilation


Secondary Outcome Measures :
  1. MRC,medical research council [ Time Frame: 28 days ]
    medical research council,Assessment of peripheral muscle strength,total points0~60,less than 48scores means ICU aquired weaknesses.

  2. 30-STS [ Time Frame: 28 days ]
    30 second sit-to-stand test.The more times, has the better muscular endurance.

  3. Barthel [ Time Frame: 28 days ]
    Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.

  4. Borg dyspnea score [ Time Frame: 28 days ]
    total points0~10,The higher the grade, the more difficulty breathing.

  5. oxygen partial pressure [ Time Frame: 28 days ]
    Partial pressure of oxygen in arterial blood,normal range is 80~100.

  6. oxygenation index [ Time Frame: 28 days ]
    The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.

  7. The diaphragmatic excursion [ Time Frame: 28 days ]
    The distance the diaphragm moves up and down during breathing,normal is 1.4cm.

  8. diaphragm contraction rate [ Time Frame: 28 days ]
    The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.

  9. diaphragm thickness diaphragm thickness fraction [ Time Frame: 28 days ]
    Thickness of diaphragm during breathing,(Diaphragm thickness at the end of inhalation-Diaphragm thickness at the end of exhalation)/Diaphragm thickness at the end of exhalation

  10. length of stay in ICU [ Time Frame: three months ]
    Length of stay in ICU

  11. LOS(length of stay) [ Time Frame: three months ]
    length of stay in hospital

  12. First time out of bed [ Time Frame: three months ]
    First time out of bed by oneself

  13. Noninvasive utilization rate [ Time Frame: 28 days ]
    Non-invasive ventilator usage

  14. mortality [ Time Frame: 28 days ]
    Alive or Dead

  15. Complication rate [ Time Frame: 28 days ]
    The incidence of new complications(pressure sores、thrombus、aspiration)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged above 18
  • The hemodynamics are stable
  • 50 < heart rate less than 120 beats/min
  • 90 < systolic blood pressure < 200mmHg
  • 55 < mean arterial pressure < 120mmHg
  • Do not increase the dose of vasopressor for at least 2 hours
  • Intracranial pressure was stable and there is no seizure within 24 hours
  • The breathing condition is stable
  • the oxygen satiety of the patient's finger vein is ≥88%
  • 10<the breathing frequency < 35 times/min

Exclusion Criteria:

  • Pregnancy
  • Acute myocardial infarction (ami)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368286


Locations
Layout table for location information
China
Chinese PLA General Hospital
Beijing, China
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Layout table for investigator information
Principal Investigator: xin li xie, Ph.D. Study Principal Investigator Chinese PLA General Hospital
Publications:
Layout table for additonal information
Responsible Party: wang kaifei, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04368286    
Other Study ID Numbers: S2018-212-01
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by wang kaifei, Chinese PLA General Hospital:
ICU,rehabilitation