- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04368286
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
Forhold
Intervensjon / Behandling
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.
Sponsor
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
Nøkkelord
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
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