Clinical trial NCT02773433: PAV vs Assist Control After Failed SBT
Official title: Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning Mode Comparison
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of patients who meet criteria for enrollment who are approached in a timely manner
timeFrame: 1 year
measure: patient enrollment number over time
timeFrame: 1 year
measure: compliance with the ventilator settings
timeFrame: 1 year
Secondary outcomes:
measure: Ventilation free days from the time patient is enrolled in the study
timeFrame: 1 year
measure: Development of ICU delirium Based on CAM ICU
timeFrame: 1 year
measure: Use of sedative or analgesic medications
timeFrame: 1 year
measure: Use of antipsychotic medications
timeFrame: 1 year
measure: Reintubations within 24 hrs
timeFrame: 1 year
measure: Length of stay in the intensive care unit
timeFrame: 1 year
measure: Length of stay in the hospital
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: In hospital mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: UofLouisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rodrigo Cavallazzi, MD
role: PRINCIPAL_INVESTIGATOR
References: