Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Respiratory Rehabilitation on ICU Patients

14. desember 2020 oppdatert av: wang kaifei, Chinese PLA General Hospital

Effects of Respiratory Rehabilitation on Patients After Extubation

Effects of respiratory rehabilitation on patients after extubation

Studieoversikt

Status

Ukjent

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Rehabilitation group
To conduct a comprehensive pulmonary rehabilitation assessment and treatment
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 inngripen: Conventional medical group
Conventional medical treatment

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

20. desember 2020

Primær fullføring (Forventet)

20. april 2021

Studiet fullført (Forventet)

20. april 2021

Datoer for studieregistrering

Først innsendt

22. april 2020

Først innsendt som oppfylte QC-kriteriene

27. april 2020

Først lagt ut (Faktiske)

29. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • S2018-212-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på pulmonary rehabilitation

3
Abonnere