Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: IRINI PATSAKI, PhD
- Telefonnummer: +30 6942064363
- E-post: ipatsaki@uniwa.gr
Studieorter
-
-
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Chalcis, Grekland
- Rekrytering
- General Hospital
-
Kontakt:
- Stiliani Andreadou, MSc
- Telefonnummer: +306942064363
- E-post: s.andreadou@gmail.com
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Nikaia, Grekland
- Rekrytering
- General Hospital "Agios Panteleimon"
-
Kontakt:
- Stavroula Fokidi, MSc
- Telefonnummer: +306942064363
- E-post: sfokidi@uniwa.gr
-
Huvudutredare:
- Stavroula Fokidi, MSc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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
Protocolized early mobilization program
|
|
Aktiv komparator: Control Group
A protocolized early mobilization program
|
Protocolized early mobilization program
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weaning sucess
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weaning duration
Tidsram: immediately after intervention
|
Duration of weaning procedure
|
immediately after intervention
|
|
Maximal Inspiratory Pressure
Tidsram: 1st day (baseline), immediately after intervention
|
Maximal inspiratory Pressure
|
1st day (baseline), immediately after intervention
|
|
Maximal expirartory pressure
Tidsram: 1st day (baseline), immediately after intervention
|
1st day (baseline), immediately after intervention
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 77916
Plan för individuella deltagardata (IPD)
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