- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01312142
Changes of Weaning Parameter in Weaning Failure Patient After Tracheostomy as a Predictor of Subsequent Weaning
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube.
The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial.
Tracheostomy has become an increasingly common intervention in ICUs, especially for patients with prolonged mechanical ventilator support.
Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
The investigators believe such improvement in pulmonary mechanic, which may reflect in the weaning parameter that respiratory therapist measured before weaning program, may be different from that measured before tracheostomy creation.
The investigators therefore hypothesized that the improvement in pulmonary mechanic for patients with weaning failure after tracheostomy may reflect on weaning parameters, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support.
Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in difficult weaning patients after tracheostomy as a predictor of subsequent successful weaning.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube1. The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial. The incidence of successful weaning is estimated around 68.8%.
Despite there is no consensus on the optimal timing of tracheostomy, patients with prolonged trans-laryngeal intubation are finally succumbed to tracheostomy, as prolonged trans-laryngeal intubation causes tissue trauma, promotes bacterial translocation and infection, making tracheostomy an increasingly common intervention in ICUs. Meanwhile, tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
We believe such improvement in pulmonary mechanics, which may reflect in the weaning parameters that respiratory therapist measured before weaning program, may be different after tracheostomy creation, especially in those patient with weaning failure. We therefore hypothesized that there may be an improvement in pulmonary mechanic for patients with weaning failure after tracheostomy, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support. Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in weaning failure patients after tracheostomy as a predictor of successful weaning.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
-
-
-
Taipei, Taiwan, 100
- Rekrutierung
- National Taiwan University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- All patients with prolonged mechanical ventilator support or difficult weaning who received tracheostomy subsequently.
Exclusion Criteria:
- Parturient
- Patient with upper airway obstruction
- Patients aged < 18 year old
- Patients who join other on going study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
patients with difficult weaning
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes of weaning parameters after tracheostomy
Zeitfenster: 5 days
|
Weaning parameters are measured before and after tracheostomy creation too see if there is any changes
|
5 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To evaluate if changes in weaning parameters will predict successful weaning
Zeitfenster: 6 months
|
We will first measure the changes of weaning parameters after tracheostomy.
If changes do occur, we would like to evaluate if it will predict subsequent weaning feasibility.
|
6 months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Jih-Shuin Jerng, MD, PhD, National Taiwan University Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 201012007RC
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Entwöhnungsfehler
-
Kanuni Sultan Suleyman Training and Research HospitalRekrutierungWeaning-Versagen der mechanischen BeatmungTürkei (türkiye)
-
Assistance Publique Hopitaux De MarseilleRekrutierungWeaning-Versagen der mechanischen BeatmungFrankreich
-
Kanuni Sultan Suleyman Training and Research HospitalRekrutierungWeaning-Versagen der mechanischen BeatmungTürkei (türkiye)
-
St. Luke's-Roosevelt Hospital CenterAbgeschlossenVent Weaning auf medizinisch-chirurgischen Intensivstationen
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalAbgeschlossenGeriatrie | Zwerchfell-Ultraschall | Weaning-Versagen der mechanischen BeatmungTruthahn
-
Istanbul University - CerrahpasaRekrutierungKritische Krankheit | Ateminsuffizienz | Beatmungsentwöhnung | Weaning-Versagen der mechanischen BeatmungTürkei (türkiye)
-
Hospital Italiano de Buenos AiresRekrutierungEntwöhnungsfehler | Mechanische Lüftung | Weaning-Versagen der mechanischen Beatmung | Intensivstation ICUArgentinien
-
Centre Hospitalier Régional d'OrléansRekrutierungSpontanatmungstest | Intensivstationen (ICUs) | Absetzinduziertes Lungenödem | Weaning-Versagen der mechanischen Beatmung | Entwöhnung durch invasive mechanische BeatmungFrankreich