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PAV vs Assist Control After Failed SBT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02773433
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Rodrigo Cavallazzi, University of Louisville

Brief Summary:

The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. The investigators plan to include patients on mechanical ventilation with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than 48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.

The secondary aims are to determine the impact of proportional assist-ventilation (PAV) versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.

Condition or disease Intervention/treatment Phase
Weaning Mode Comparison Other: Proportional Assist Ventilation Not Applicable

Detailed Description:

Overview of Design Randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (PaO2/Fio2 ratio > 200, FiO2 < 0.5 & PEEP <8) for a period not greater than 48 hrs.

Hypothesis The investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. The investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. The investigators also propose that PAV mode ventilation will be superior to ACV based on clinical outcome measurements.

Study Subjects Consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. The study will be performed in the intensive care units of University of Louisville and Jewish Hospital in Louisville, KY.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
Study Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: PAV group
Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial
Other: Proportional Assist Ventilation
Other Name: PAV

No Intervention: Control group
Using Volume Assist Control mode after failed SBT

Primary Outcome Measures :
  1. proportion of patients who meet criteria for enrollment who are approached in a timely manner [ Time Frame: 1 year ]
  2. patient enrollment number over time [ Time Frame: 1 year ]
  3. compliance with the ventilator settings [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Ventilation free days from the time patient is enrolled in the study [ Time Frame: 1 year ]
  2. Development of ICU delirium Based on CAM ICU [ Time Frame: 1 year ]
  3. Use of sedative or analgesic medications [ Time Frame: 1 year ]
  4. Use of antipsychotic medications [ Time Frame: 1 year ]
  5. Reintubations within 24 hrs [ Time Frame: 1 year ]
  6. Length of stay in the intensive care unit [ Time Frame: 1 year ]
  7. Length of stay in the hospital [ Time Frame: 1 year ]
  8. Adverse events [ Time Frame: 1 year ]
  9. In hospital mortality [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >18 yrs old
  2. Patient or proxy available in the hospital to consent
  3. Receipt of invasive mechanical ventilation on low ventilator support (Po2/Fio2 ratio >200, Fio2 <60% & PEEP <8) for a period not greater than 48 hrs

Exclusion Criteria:

  1. Pregnant patients
  2. Terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality > 50%)
  3. Severely depressed respiratory drive
  4. Receipt of neuromuscular blocker
  5. Bronchopleural fistula
  6. Inability to obtain consent from patients or their proxies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02773433

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United States, Kentucky
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: Rodrigo Cavallazzi, MD University of Louisville
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Responsible Party: Rodrigo Cavallazzi, Assistant Professor of Medicine, University of Louisville Identifier: NCT02773433    
Other Study ID Numbers: 14.1009
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016