PAV vs Assist Control After Failed SBT

NCT02773433 | Completed DMC

• 1 other identifier: 14.1009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Mode Comparison

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

PAV group

EXPERIMENTAL

Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial

Other: Proportional Assist Ventilation

Control group

NO INTERVENTION

Using Volume Assist Control mode after failed SBT

Interventions

Proportional Assist Ventilation OTHER

Also known as: PAV

PAV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

UofLouisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Rodrigo Cavallazzi, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 16, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (1)