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Mechanical VentilationNCT00631683

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

An observational study of Mechanical Ventilation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mechanical Ventilation
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2008to Feb 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Mechanically ventilated patients at Memorial Hermann Hospital MICU.

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Hermann Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Use of Flo-Trac/Vigileo (TM) for Hemodynamic Monitoring During Discontinuation From Mechanical Ventilation

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.

Read the 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 failure occurs in up to 25% of patients who meet criteria for weaning, especially in those with underlying COPD or heart failure (1). Weaning failure is well known to prolong intensive care unit (ICU) stay, and to increase morbidity and mortality in critically ill patients. Early identification and treatment of causes of weaning failure is of paramount importance to improve outcome in difficult to wean patients.

Although respiratory system failure is the most common cause of weaning failure, occult cardiovascular insufficiency occurs very often in critically ill patients, and it can contribute to, or be the only cause of weaning failure in many patients (2). Recognition of cardiovascular origin of weaning failure is crucial since the use of vasodilators and/or diuretics may result in successful weaning (1).

Cardiovascular instability during liberation from mechanical ventilation was first described more than 30 years ago by Beach et al (3) in post-operative cardiac surgery patients. Since then, a few other studies have described the hemodynamic changes both in patients who underwent successful and unsuccessful weaning form mechanical ventilation (1,4,5,6,7). Lemaire et al. (4) emphasized the use of a pulmonary artery catheter as the "gold standard" to detect left ventricular dysfunction during spontaneous breathing trial (SBT). They reported a markedly increased in pulmonary artery occlusion pressure (PAOP) in patients who were suffering from COPD or heart failure who failed to wean from mechanical wentilation. Jubran et al. (5) reported an increase in PAOP, decreased mixed venous oxygen saturation (SvO2) and an increase in the oxygen extraction ratio in a group of patients who failed to wean from mechanical ventilation. In contrast, De Backer et al. (6) described an increase in cardiac index in a group of patients who were successfully weaned after cardiac surgery. A recently published study by Frazier et al. (7) corroborated previous data by comparing the hemodynamic changes between a group of patients who were successfully weaned and a group of patients who failed to wean from mechanical ventilation. The cardiac output and stroke volume were estimated by the differential Fick partial rebreathing technique, with carbon dioxide as the indicator substance. The group of patients who were successfully weaned had a statistical significant increase in both stroke volume and cardiac index, unlike the group that failed weaning.

The physiologic changes that explain the above mentioned findings in hemodynamic parameters during weaning are complex and not fully understood (1). It is well known that weaning can place an excessive burden on the heart and it can be considered a form of "exercise" (2). As studied by exercise physiologists, the increase in oxygen consumption during exercise in healthy individuals is matched both by an increase in cardiac output and oxygen extraction. In patients with overt heart failure, the increase in cardiac output is inadequate, and the predominant response constitutes and increase in oxygen extraction. Return to spontaneous breathing induces alteration in intrathoracic pressures that influence cardiovascular function, producing, among other changes, an increase in venous return. Other postulated physiologic changes include increase sympathetic tone, weaning-induced myocardial ischemia and increased ventricular interdependence (2).

The recognition of cardiac origin of weaning failure is of vital importance. Unfortunately, the clinical signs of patients who fail weaning because of acute heart failure (tachypnea, tachycardia, anxiety, etc) are often difficult to distinguish from signs of respiratory failure. Reliable bedside minimally invasive monitoring tools and tests need to be developed to help the clinician in identifying these patients and help titrate cardiovascular therapies during weaning trials. Currently, the list of such tools is short and the validity of each technique in different situations is unknown (2).

Cardiovascular dysfunction may be the missing piece in predicting weaning success. Cardiovascular monitoring can be useful in identifying and managing patients who fail to wean due to lack of cardiac reserve.

We propose the use of Flo-Trac/VigileoTM, a semi-invasive technique that estimates cardiac output from the arterial pressure waveform, as a tool for cardiac monitoring during the process of weaning from mechanical ventilation.

References:

  1. Richard C and Teboul JL. Weaning failure from cardiovascular origin. Intensive Care Med 2005;31:1605-1607
  2. Pinsky MR. Breathing as exercise. Intensive care Med 2000;26:1164-1166
  3. Beach T, Millen E, Grenvik A. Hemodynamic response to discontinuation from mechanical ventilation. Crit Care med 1973;1:85-90
  4. Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I and Zapol W. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology 1998;69:171-179
  5. Jubran A, Mathru M, dries D and Tobin MJ. Continuous recordings from Mixed Venous Oxygen Saturation during Weaning from Mechanical Ventilation and the Ramifications Thereof. Am J Respir Crit Care Med 1998:158:1763-1769
  6. De Backer D, El Haddad P, Preiser JC and Vincent JL. Hemodynamic responses to successful weaning from mechanical ventilation after cardiovascular surgery. Intensive Care Med 2000;26:1201-1206
  7. Frazier SK et al. Hemodynamic changes during discontinuation of mechanical ventilation in medical intensive care unit patients. Am J Crit Care 2006;15:580-593

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00631683
Study groupRoleWhat they receive
MICU-1Mechanically ventilated patients who are about to start a weaning trial at the medical intensive care unit of Memorial Hermann Hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 and 9 months

Secondary outcomes (2)
  1. To compare the hemodynamic changes between patients who had successful and those who had unsuccessful discontinuation from mechanical ventilation

    Measured: 2 and 9 months

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

    Measured: 2 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionFeb 2008
  4. Study completionFeb 2008 (estimated)

Why it stopped: Terms for legal agreements between institution and Sponsor could not be made.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00631683
Sponsor's protocol ID
HSC-MS-07-0368
Status last verified
Nov 2020
First submitted
22 Feb 2008
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mechanical Ventilation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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