NCT01131390

Ventilator Settings and Comfort

What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Bridgeport Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

No studies have been done to examine whether patients with obstructive lung disease and obesity are more comfortable on some ventilator settings than on others. The purpose of the current study is to examine this question systematically.

Detailed description

Methods: Demographic and physiologic data will be recorded. Investigators will begin measurements more than 60 minutes after last dose of sedative and measurements to occur when no major interventions are planned or medications are scheduled. Then patients will undergo the following ventilator settings (all of which are within ranges ordinarily employed) in random order for 3 minutes of each setting (pressures measured midway i.e. 1.5 minutes - at each interval to ensure safety; stopped if static airway pressure\>30 cmH2O): 1. Assist control 1. Tidal volumes of 6 ml/kg, 8 ml/kg and 10 ml/kg 2. Flow regimes: constant (CF) and decelerating (dec) at 40, 60 and 80 L/min; 2. Pressure support (PS) 0, 10 and 20 cmH2O with PEEP=5 cmH2O Patients will be randomized to receive the following in either forward or reverse order: CF60L/min in 6 then 8 then 10 ml/kg; then at 8 ml/kg CF40, Dec40, Dec60, CF60, CF80, Dec80; then PS=0, 10, 20 cmH2O. In the last 30 second of each setting, patients will be asked to indicate their level of comfort (1-10 in increasing comfort) using a visual analog Borg Score (when they can see/write) or to indicate on their fingers when they cannot write.

Conditions

• Obesity
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Ventilator setting changes	Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-27
• Last updated: 2011-06-22

Locations

1 site across 1 country: United States