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Changes of Weaning Parameter in Weaning Failure Patient After Tracheostomy as a Predictor of Subsequent Weaning

19. desember 2011 oppdatert av: National Taiwan University Hospital

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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

100

Kontakter og plasseringer

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Studiesteder

      • Taipei, Taiwan, 100
        • Rekruttering
        • National Taiwan University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with difficult weaning and received subsequent tracheostomy

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
patients with difficult weaning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes of weaning parameters after tracheostomy
Tidsramme: 5 days
Weaning parameters are measured before and after tracheostomy creation too see if there is any changes
5 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate if changes in weaning parameters will predict successful weaning
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jih-Shuin Jerng, MD, PhD, National Taiwan University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2011

Primær fullføring (Forventet)

1. april 2012

Studiet fullført (Forventet)

1. april 2012

Datoer for studieregistrering

Først innsendt

8. mars 2011

Først innsendt som oppfylte QC-kriteriene

9. mars 2011

Først lagt ut (Anslag)

10. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. desember 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2011

Sist bekreftet

1. desember 2011

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 201012007RC

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