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

NCT01312142 | Unknown

• 1 other identifier: 201012007RC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (1)

• Changes of weaning parameters after tracheostomy

  Weaning parameters are measured before and after tracheostomy creation too see if there is any changes

  5 days

Secondary Outcomes (1)

• To evaluate if changes in weaning parameters will predict successful weaning

  6 months

Study Arms (1)

patients with difficult weaning

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with difficult weaning and received subsequent tracheostomy

You may qualify if:

• All patients with prolonged mechanical ventilator support or difficult weaning who received tracheostomy subsequently.

You may not qualify if:

• Parturient
• Patient with upper airway obstruction
• Patients aged \< 18 year old
• Patients who join other on going study

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• Lim CK, Ruan SY, Lin FC, Wu CL, Chang HT, Jerng JS, Wu HD, Yu CJ. Effect of Tracheostomy on Weaning Parameters in Difficult-to-Wean Mechanically Ventilated Patients: A Prospective Observational Study. PLoS One. 2015 Sep 17;10(9):e0138294. doi: 10.1371/journal.pone.0138294. eCollection 2015.

  PMID: 26379127 DERIVED

Study Officials

• Jih-Shuin Jerng, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Shuin Jerng, MD, PhD

CONTACT

0972651075; jsjerng@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

TW (1)