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

NCT00631683 | Withdrawn

• 1 other identifier: HSC-MS-07-0368
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• To describe the hemodynamic changes during the process of discontinuation from mechanical ventilation with the aid of Flo-Trac/Vigileo (TM)

  2 and 9 months

Secondary Outcomes (2)

• To compare the hemodynamic changes between patients who had successful and those who had unsuccessful discontinuation from mechanical ventilation

  2 and 9 months

• To determine if the lack of increase in cardiac output during discontinuation from mechanical ventilation is associated with and predictive of weaning failure

  2 and 9 months

Study Arms (1)

MICU-1

Mechanically ventilated patients who are about to start a weaning trial at the medical intensive care unit of Memorial Hermann Hospital.

Eligibility Criteria

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

Study Population

Mechanically ventilated patients at Memorial Hermann Hospital MICU.

You may qualify if:

• 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
• hours free from sedation (opioids/benzodiazepine)
• hours free from sedation in case patient is on Propofol
• Systolic blood pressure above 90 mmHg and below 180 mmHg

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Study Officials

• Roberto F Casal, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

US (1)