PAV vs Assist Control After Failed SBT

Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Weaning Mode Comparison
• Intervention / Treatment: Other: Proportional Assist Ventilation

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • UofLouisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAV group; Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial	Other: Proportional Assist Ventilation; Other Names: PAV
No Intervention: Control group; Using Volume Assist Control mode after failed SBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients who meet criteria for enrollment who are approached in a timely manner	1 year
patient enrollment number over time	1 year
compliance with the ventilator settings	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	1 year
Ventilation free days from the time patient is enrolled in the study	1 year
Development of ICU delirium Based on CAM ICU	1 year
Use of sedative or analgesic medications	1 year
Use of antipsychotic medications	1 year
Reintubations within 24 hrs	1 year
Length of stay in the intensive care unit	1 year
Length of stay in the hospital	1 year
In hospital mortality	1 year

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Rodrigo Cavallazzi, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 16, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14.1009