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PAV vs Assist Control After Failed SBT

NCT ID: NCT02773433

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Weaning Mode Comparison

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAV group

Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial

Group Type EXPERIMENTAL

Proportional Assist Ventilation

Intervention Type OTHER

Control group

Using Volume Assist Control mode after failed SBT

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Proportional Assist Ventilation

Intervention Type OTHER

Other Intervention Names

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PAV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Cavallazzi

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Cavallazzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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UofLouisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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14.1009

Identifier Type: -

Identifier Source: org_study_id