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Completed

NCT Number: NCT02773433

PAV vs Assist Control After Failed SBT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UofLouisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 yrs old
  • Patient or proxy available in the hospital to consent
  • 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

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

Treatment and study plan

Proportional Assist Ventilation

Other

Other names: PAV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 16, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.