Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: IRINI PATSAKI, PhD
- Numéro de téléphone: +30 6942064363
- E-mail: ipatsaki@uniwa.gr
Lieux d'étude
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Chalcis, Grèce
- Recrutement
- General Hospital
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Contact:
- Stiliani Andreadou, MSc
- Numéro de téléphone: +306942064363
- E-mail: s.andreadou@gmail.com
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Nikaia, Grèce
- Recrutement
- General Hospital "Agios Panteleimon"
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Contact:
- Stavroula Fokidi, MSc
- Numéro de téléphone: +306942064363
- E-mail: sfokidi@uniwa.gr
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Chercheur principal:
- Stavroula Fokidi, MSc
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: Control Group
A protocolized early mobilization program
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Protocolized early mobilization program
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Weaning sucess
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weaning duration
Délai: immediately after intervention
|
Duration of weaning procedure
|
immediately after intervention
|
|
Maximal Inspiratory Pressure
Délai: 1st day (baseline), immediately after intervention
|
Maximal inspiratory Pressure
|
1st day (baseline), immediately after intervention
|
|
Maximal expirartory pressure
Délai: 1st day (baseline), immediately after intervention
|
1st day (baseline), immediately after intervention
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 77916
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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