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HFCWO in Prolonged Mechanical Ventilation Patients

2 mars 2014 mis à jour par: TCVGH, Taichung Veterans General Hospital

High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial

The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal intubation.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

For over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of HFCWO in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. However, these outcomes of HFCWO on PMV patients remain unknown.

This parallel-design, randomized controlled trial aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in PMV patients with intra-tracheal intubation. Moreover, the safety and tolerance/comfort of HFCWO in PMV patients after removal of endotracheal tubes were also evaluated.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Taïwan
      • Taichung, Taïwan, 40705
        • Taichung Veterans General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
  2. age ≥20 year-old
  3. having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
  4. alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
  5. scheduled extubation within 24 hours after enrollment
  6. without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)

Exclusion Criteria:

1. those who had undergone tracheostomy

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HFCWO
HFCWO for 15 min twice a day
Dispositif: HFCWO (Hill-Rom Vest™ Airway Clearance System)
study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
Autres noms:
  • Hill-Rom Vest™ Airway Clearance System
Comparateur placebo: placebo
not to receive high-frequency chest wall oscillation (HFCWO)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Effectiveness as determined by weaning success rates
Délai: up to 5 days after extubation
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
up to 5 days after extubation
Effectiveness as determined by daily clearance volume of sputum
Délai: up to 5 days after extubation
The daily clearance volume of sputum was determined by the numbers of sputum suction per day
up to 5 days after extubation
Effectiveness as determined by serial changes in sputum coloration
Délai: up to 5 days after extubation
The sputum coloration was determined by the Color Card for Body Fluid (CCBF). The CCBF was designed to have 27 different categories to describe the color of the body fluid. Each category was assigned an Arabic numeral and the larger the Arabic numeral, the darker the color of the body fluid. The scoring of sputum coloration was based on the perception of the interviewer who was blinded to the intervention.
up to 5 days after extubation
Effectiveness as determined by chest X-ray improvement rates
Délai: up to 5 days after extubation
Baseline and follow-up CXRs were taken on the day of extubation and on the 5th day after extubation, respectively, in both groups. Serial changes in CXR were graded as "improved", "no change", or "progressed", as determined by the severity of lung infiltrates, which were defined by two independent chest specialists blinded to the study groupings. If no consistency between two specialists, the grading would be judged by the third chest specialist.
up to 5 days after extubation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
safety as determined by the changes of blood pressures before and after HFCWO
Délai: up to 5 days after extubation
systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
safety as determined by the changes of heart rates before and after HFCWO
Délai: up to 5 days after extubation
Heart rates (HR) was recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
safety as determined by the changes of respiratory rates (RR) before and after HFCWO
Délai: up to 5 days after extubation
Respiratory rates (RR) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
Délai: up to 5 days after extubation
Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
tolerance/comfort as determined by Modified Borg Scale (MBS)
Délai: up to 5 days after extubation
MBS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
up to 5 days after extubation
tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
Délai: up to 5 days after extubation
HAS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
up to 5 days after extubation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Taichung Veterans General Hospital

Les enquêteurs

  • Chercheur principal: Chieh-Liang Wu, Ph.D., Taichung Veterans General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2011

Achèvement primaire (Réel)

1 décembre 2012

Achèvement de l'étude (Réel)

1 décembre 2012

Dates d'inscription aux études

Première soumission

20 février 2014

Première soumission répondant aux critères de contrôle qualité

2 mars 2014

Première publication (Estimation)

4 mars 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 mars 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 mars 2014

Dernière vérification

1 mars 2014

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • C10216
  • huang5598 (Autre identifiant: Taichung VGH)

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