Effects of Respiratory Rehabilitation on ICU Patients

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04368286
Collaborator
(none)
100
2
4

Study Details

Study Description

Brief Summary

Effects of respiratory rehabilitation on patients after extubation

Condition or Disease Intervention/Treatment Phase
  • Behavioral: pulmonary rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Respiratory Rehabilitation on Patients After Extubation
Anticipated Study Start Date :
Dec 20, 2020
Anticipated Primary Completion Date :
Apr 20, 2021
Anticipated Study Completion Date :
Apr 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reintubation rates [28 days]

    The artificial airway was established again for invasive mechanical ventilation

Secondary Outcome Measures

  1. MRC,medical research council [28 days]

    medical research council,Assessment of peripheral muscle strength,total points0~60,less than 48scores means ICU aquired weaknesses.

  2. 30-STS [28 days]

    30 second sit-to-stand test.The more times, has the better muscular endurance.

  3. Barthel [28 days]

    Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.

  4. Borg dyspnea score [28 days]

    total points0~10,The higher the grade, the more difficulty breathing.

  5. oxygen partial pressure [28 days]

    Partial pressure of oxygen in arterial blood,normal range is 80~100.

  6. oxygenation index [28 days]

    The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.

  7. The diaphragmatic excursion [28 days]

    The distance the diaphragm moves up and down during breathing,normal is 1.4cm.

  8. diaphragm contraction rate [28 days]

    The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.

  9. diaphragm thickness diaphragm thickness fraction [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 [three months]

    Length of stay in ICU

  11. LOS(length of stay) [three months]

    length of stay in hospital

  12. First time out of bed [three months]

    First time out of bed by oneself

  13. Noninvasive utilization rate [28 days]

    Non-invasive ventilator usage

  14. mortality [28 days]

    Alive or Dead

  15. Complication rate [28 days]

    The incidence of new complications(pressure sores、thrombus、aspiration)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

  • Principal Investigator: xin li xie, Ph.D., Study Principal Investigator Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
wang kaifei, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT04368286
Other Study ID Numbers:
  • S2018-212-01
First Posted:
Apr 29, 2020
Last Update Posted:
Dec 16, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by wang kaifei, Principal Investigator, Chinese PLA General Hospital

Study Results

No Results Posted as of Dec 16, 2020