Ventilator Settings and Comfort

NCT ID: NCT01131390

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Ventilator setting changes

Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (>18 y) admitted to the MICU of Bridgeport Hospital on mechanical ventilation for:

• Exacerbation of COPD (smoking history>20 pkyrs AND chest radiographic or function abnormalities supportive of the diagnosis); OR
• Body mass index>40 kg/m2 and acute on chronic hypercapnic respiratory failure.
• Patients must be awake, not have received narcotics for more than 2 hours and possess capacity to consent themselves.
• Patients must have recovered sufficiently from their acute illness to be candidates for weaning per hospital protocol i.e. not in shock, no pressors and PaO2:FiO2>120.

Exclusion Criteria

• Patients extubated for comfort care only.
• Patients with successful weaning trial that otherwise clinically requires extubation.
• Patients with unresolved pneumonia, unresolved congestive heart failure, neuromuscular disease or kyphoscoliosis-related respiratory failure will also be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bridgeport Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bridgeport Hospital

Principal Investigators

Constantine Manthous, MD

Role: PRINCIPAL_INVESTIGATOR

Bridgeport Hospital

Locations

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Constantine Manthous, MD

Role: primary

pcmant@bpthosp.org

203-384-4581

Other Identifiers

Bpthosp11001

Identifier Type: -

Identifier Source: org_study_id