Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)

25. maj 2026 opdateret af: IRINI PATSAKI, University of West Attica
Patients in critical condition, due to their prolonged stay in the Intensive Care Unit (ICU), the severity of the underlying disease, and potential adverse effects of hospitalization, may develop serious complications, such as muscle atrophy and weakness, which also affect the respiratory muscles. It is characteristic that within the first 18-69 hours of mechanical ventilation (MV), proteolytic processes occur that lead to rapid atrophy of the diaphragm. Diaphragmatic dysfunction acquired during the ICU stay thus appears to have an adverse effect on weaning from mechanical ventilation, length of ICU stay, length of hospital stay, functional status, quality of life, and mortality within the ICU and the hospital. Inspiratory muscle training (IMT) has been identified as an intervention that could augment weaning, preventing the dedtrimental effects of MV. The purpose of this study is to assess the effect of an IMT protocol in weaning success of ICU patients. Specifically, an electronic device will be used that incorporates a tapered flow resistive technique.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

It is estimated that 40% of the duration of mechanical ventilation is devoted to the weaning process. A length of stay in the ICU of more than 7 days appears to be associated with a 27,9% risk of developing infections. Furthermore, the mortality rate is higher in patients with infections. Additionally, the daily cost of hospitalizing a patient on mechanical ventilation is estimated at €1,590-€1,657, while this varies depending on the interventions required. The burden on the National Health System from the prolonged stay of patients in the ICU, as well as from the complications that will arise, increases exponentially.

It has been found that implementing an IMT program can lead to rapid and successful extubation of the patient, while early mobilization can accelerate timely discharge from the ICU. This optimizes the cost-effectiveness ratio in intensive care units.

The investigators believe that implementing an IMT program will maximize the effectiveness of the early mobilization program for ICU patients. Thus, the investigators believe it will provide valuable insights into the rehabilitation needs of critically ill patients, contributing to earlier weaning from mechanical ventilation and transition to the next level of care. The investigators hypothesize that the implementation of such an intervention program will reduce the length of hospital stay, while also lowering the cost of daily care.

This is a randomized control trial that investigates the effectiveness of an inspiratory muscle training program in successful weaning of mechanically ventilated patients for at least 72 hours. Both experimental groups will receive a protocolised early mobilization program. IMT intervention will be applied till ICU discharge once a day for 5 days/week initiating with a load of 40% of maximal inspiratory pressure (MIP). Primary outcome will be a successful weaning from MV. And secondary includes MV duration, MIP, maximal expiratory pressure (MEP), ICU and hopsital length of stay.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Grækenland
      • Chalcis, Grækenland
        • Rekruttering
        • General Hospital
        • Kontakt:
      • Nikaia, Grækenland
        • Rekruttering
        • General Hospital "Agios Panteleimon"
        • Kontakt:
        • Ledende efterforsker:
          • Stavroula Fokidi, MSc

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • ≥ 72h invasive mechanical ventilation
  • adequate co-operativeness as assessed by 5SQ ≥ 3.

Exclusion Criteria:

  • terminal condition or palliative care
  • neuromuscular or neurological conditions prior to ICU admission

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IMT Group

Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets.

Additional, a protocolized early mobilization program will be perfromed.
Andet: IMT
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets
Andet: Early mobilization
Protocolized early mobilization program
Aktiv komparator: Control Group
A protocolized early mobilization program
Andet: Early mobilization
Protocolized early mobilization program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weaning sucess
Tidsramme: immediately after intervention
Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal
immediately after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weaning duration
Tidsramme: immediately after intervention
Duration of weaning procedure
immediately after intervention
Maximal Inspiratory Pressure
Tidsramme: 1st day (baseline), immediately after intervention
Maximal inspiratory Pressure
1st day (baseline), immediately after intervention
Maximal expirartory pressure
Tidsramme: 1st day (baseline), immediately after intervention
1st day (baseline), immediately after intervention

Samarbejdspartnere og efterforskere

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

Sponsor

University of West Attica

Samarbejdspartnere

General Hospital of Nikaia "Saint Panteleimon"
General Hospital of Chalkida

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 (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 77916

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mekanisk ventilerede ICU-patienter

Kliniske forsøg med IMT

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cameroon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner