Status:

WITHDRAWN

Assessment of Hemodynamic Changes During Weaning From Mechanical Ventilation With Flo-Trac Vigileo (TM) Monitor.

Lead Sponsor:

The University of Texas Health Science Center, Houston

Collaborating Sponsors:

Edwards Lifesciences

Conditions:

Mechanical Ventilation

Eligibility:

All Genders

18+ years

Brief Summary

Failure to wean from mechanical ventilation (failure to get the patients off the breathing machine) is associated with prolonged stay in the intensive care unit and increased risk of death. Some patie...

Detailed Description

In the process of liberation or discontinuation from mechanical ventilation (also commonly referred as "weaning") the goal is to achieve spontaneous breathing and ultimately extubation. Weaning failur...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Arterial line in place
  • Normal sinus rhythm by electrocardiographic monitoring
  • Mechanical ventilation for at least 24 hours
  • Ventilation via oral or nasal endotracheal tube
  • Patient meets the following weaning criteria before starting weaning protocol:
  • PaO2/FiO2 ratio \>200
  • FiO2 equal or less than 50%
  • Positive end-expiratory pressure (PEEP) 5cm H20 or less
  • Respiratory frequency/Tidal volume ratio less 105
  • Respiratory rate \< 30 breaths/min
  • Presence of cough and gag reflex
  • 12 hours free from sedation (opioids/benzodiazepine)
  • 2 hours free from sedation in case patient is on Propofol
  • Systolic blood pressure above 90 mmHg and below 180 mmHg
  • Heart rate below 130 beats/min

Exclusion

  • Known neurological disorder that might impair ventilatory drive
  • Known neuromuscular disease
  • Inotropic or vasopressor infusion
  • Cardiac pacemaker
  • Terminal condition

Key Trial Info

Start Date :

February 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2008

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00631683

Start Date

February 1 2008

End Date

February 1 2008

Last Update

November 5 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Memorial Hermann Hospital

Houston, Texas, United States, 77030