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PAV vs Assist Control After Failed SBT

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ClinicalTrials.gov Identifier: NCT02773433
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Rodrigo Cavallazzi, University of Louisville

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • proportion of patients who meet criteria for enrollment who are approached in a timely manner [ Time Frame: 1 year ]
  • patient enrollment number over time [ Time Frame: 1 year ]
  • compliance with the ventilator settings [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • Ventilation free days from the time patient is enrolled in the study [ Time Frame: 1 year ]
  • Development of ICU delirium Based on CAM ICU [ Time Frame: 1 year ]
  • Use of sedative or analgesic medications [ Time Frame: 1 year ]
  • Use of antipsychotic medications [ Time Frame: 1 year ]
  • Reintubations within 24 hrs [ Time Frame: 1 year ]
  • Length of stay in the intensive care unit [ Time Frame: 1 year ]
  • Length of stay in the hospital [ Time Frame: 1 year ]
  • Adverse events [ Time Frame: 1 year ]
  • In hospital mortality [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PAV vs Assist Control After Failed SBT
Official Title  ICMJE Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weaning Mode Comparison
Intervention  ICMJE Other: Proportional Assist Ventilation
Other Name: PAV
Study Arms  ICMJE
  • Experimental: PAV group
    Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial
    Intervention: Other: Proportional Assist Ventilation
  • No Intervention: Control group
    Using Volume Assist Control mode after failed SBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773433
Other Study ID Numbers  ICMJE 14.1009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodrigo Cavallazzi, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Cavallazzi, MD University of Louisville
PRS Account University of Louisville
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP