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Effects of Respiratory Rehabilitation on ICU Patients

14. december 2020 opdateret af: wang kaifei, Chinese PLA General Hospital

Effects of Respiratory Rehabilitation on Patients After Extubation

Effects of respiratory rehabilitation on patients after extubation

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rehabilitation group
To conduct a comprehensive pulmonary rehabilitation assessment and treatment
Adfærdsmæssigt: 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.
Ingen indgriben: Conventional medical group
Conventional medical treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reintubation rates
Tidsramme: 28 days
The artificial airway was established again for invasive mechanical ventilation
28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MRC，medical research council
Tidsramme: 28 days
medical research council，Assessment of peripheral muscle strength，total points0~60，less than 48scores means ICU aquired weaknesses.
28 days
30-STS
Tidsramme: 28 days
30 second sit-to-stand test.The more times, has the better muscular endurance.
28 days
Barthel
Tidsramme: 28 days
Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.
28 days
Borg dyspnea score
Tidsramme: 28 days
total points0~10,The higher the grade, the more difficulty breathing.
28 days
oxygen partial pressure
Tidsramme: 28 days
Partial pressure of oxygen in arterial blood,normal range is 80~100.
28 days
oxygenation index
Tidsramme: 28 days
The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.
28 days
The diaphragmatic excursion
Tidsramme: 28 days
The distance the diaphragm moves up and down during breathing,normal is 1.4cm.
28 days
diaphragm contraction rate
Tidsramme: 28 days
The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.
28 days
diaphragm thickness diaphragm thickness fraction
Tidsramme: 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
28 days
length of stay in ICU
Tidsramme: three months
Length of stay in ICU
three months
LOS(length of stay)
Tidsramme: three months
length of stay in hospital
three months
First time out of bed
Tidsramme: three months
First time out of bed by oneself
three months
Noninvasive utilization rate
Tidsramme: 28 days
Non-invasive ventilator usage
28 days
mortality
Tidsramme: 28 days
Alive or Dead
28 days
Complication rate
Tidsramme: 28 days
The incidence of new complications(pressure sores、thrombus、aspiration)
28 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese PLA General Hospital

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

20. december 2020

Primær færdiggørelse (Forventet)

20. april 2021

Studieafslutning (Forventet)

20. april 2021

Datoer for studieregistrering

Først indsendt

22. april 2020

Først indsendt, der opfyldte QC-kriterier

27. april 2020

Først opslået (Faktiske)

29. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • S2018-212-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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