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

This study has been withdrawn prior to enrollment.
(Terms for legal agreements between institution and Sponsor could not be made.)
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00631683
First received: February 22, 2008
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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 patients have difficulty successfully getting off the ventilator and breathing on their own. Usually this difficulty is due to lung problems. But sometimes it is due to heart problems, or heart failure. To improve a patient's chances of successfully getting off the ventilator early, it is helpful to the doctors to know if patient has heart failure and to measure how severe. With the new monitoring system being studied here, doctors may be able to detect and measure heart failure more easily.

A new monitor (Vigileo TM) that is connected with a specific cable (Flo-TracTM) to a catheter that is inside the patient's artery (arterial line) has lately been developed. This monitor can estimate the amount of blood that the heart is pumping per minute, known as cardiac output. The heart is supposed to pump blood harder when a patient is being weaned from the breathing machine. With the above mentioned monitor, we hope to detect those patients whose hearts are weak and are not pumping as hard as they should.


Condition
Mechanical Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Flo-Trac/Vigileo (TM) for Hemodynamic Monitoring During Discontinuation From Mechanical Ventilation

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • To describe the hemodynamic changes during the process of discontinuation from mechanical ventilation with the aid of Flo-Trac/Vigileo (TM) [ Time Frame: 2 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the hemodynamic changes between patients who had successful and those who had unsuccessful discontinuation from mechanical ventilation [ Time Frame: 2 and 9 months ] [ Designated as safety issue: No ]
  • To determine if the lack of increase in cardiac output during discontinuation from mechanical ventilation is associated with and predictive of weaning failure [ Time Frame: 2 and 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
MICU-1
Mechanically ventilated patients who are about to start a weaning trial at the medical intensive care unit of Memorial Hermann Hospital.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mechanically ventilated patients at Memorial Hermann Hospital MICU.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Known neurological disorder that might impair ventilatory drive
  • Known neuromuscular disease
  • Inotropic or vasopressor infusion
  • Cardiac pacemaker
  • Terminal condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631683

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Edwards Lifesciences
Investigators
Principal Investigator: Roberto F Casal, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Roberto F. Casal, MD, The University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00631683     History of Changes
Other Study ID Numbers: HSC-MS-07-0368
Study First Received: February 22, 2008
Last Updated: May 14, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014