Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
14. februar 2022 oppdatert av: JinyanXing, The Affiliated Hospital of Qingdao University
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility.
Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
47
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zehua Dong, Dr.
- Telefonnummer: 86-0532-82919386
- E-post: liuyingwallace@163.com
Studiesteder
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Qingdao, Kina, 266003
- Rekruttering
- Neuromuscular electrical stimulation
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Ta kontakt med:
- Zehua Dong, Dr.
- Telefonnummer: 18661803112
- E-post: liuyingwallace@163.com
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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 til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Prolonged MV(>72 h);
- Written informed consent was obtained from the patients or their relatives
Exclusion Criteria:
- Previous neuromuscular disease;
- Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
- Thoracic or diaphragmatic malformation;
- Local skin damage and infection;
- Indwelling a temporary or permanent pacemaker;
- Severe obesity(BMI>35 kg/m2)
- Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
- Patients with an expected survival time of less than 7 days or with palliative care
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 |
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Eksperimentell: NMSE Group
Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
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NMES was performed using a portable machine.The negative electrodes were placed in the motor points of the following muscles: chest muscles (pectoralis major muscle fibres) and rectus abdominis muscles bilaterally.
A second (positive) electrode was positioned distally to the first, at a site close to the muscle that was being electrically stimulated, totalling 1 channel with 2 electrodes for each muscle .
Each NMES session lasted 30 min.
The following parameters were used: 50 Hz frequency, pulse duration 300 ms, rise time 1 s, stimulus time (ON) 3 s, decay time 1 s, and relaxation time (OFF) 10 s.
Intensity was increased until muscle contraction was visible or could be identified through palpation.
In conscious patients, intensity was adjusted according to their tolerance.
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Ingen inngripen: CPT group
The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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diaphragmatic thickening fraction(DTF)
Tidsramme: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
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DTF shows varied thickness of the diaphragm at end-expiration and end-inspiration.
Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively.
DTF was calculated by DTF=(DTei DTee)/DTee 100%.
Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value
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baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Parasternal Intercostal Muscle Ultrasound
Tidsramme: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
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A 10- to 15-MHz linear array transducer was positioned perpendicular to the anterior thorax surface in the longitudinal scan, at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the sternal edge with a window visualizing the second and third ribs. .
Using M-mode, the ultrasound beam was perpendicularly directed at the midsection of the muscle, where it is the thinnest at end-expiration.
The thickness of the parasternal intercostal muscle was measured on frozen images at end expiration and at peak inspiration.
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baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
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Andre resultatmål
Resultatmål |
Tidsramme |
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ventilator-free days at 28 days
Tidsramme: 28 days
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28 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Jinyan Xing, Dr., The Affiliated Hospital of Qingdao University
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 (Faktiske)
1. februar 2022
Primær fullføring (Forventet)
31. august 2022
Studiet fullført (Forventet)
31. august 2022
Datoer for studieregistrering
Først innsendt
8. januar 2022
Først innsendt som oppfylte QC-kriteriene
27. januar 2022
Først lagt ut (Faktiske)
1. februar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DZH20220104
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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