Ventilator Settings and Comfort
Primary Purpose
Obesity, Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ventilator setting changes
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity
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.
Sites / Locations
- Bridgeport HospitalRecruiting
Outcomes
Primary Outcome Measures
Patients' comfort
Borg score of patients' dyspnea
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01131390
Brief Title
Ventilator Settings and Comfort
Official Title
What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bridgeport Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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):
Assist control
Tidal volumes of 6 ml/kg, 8 ml/kg and 10 ml/kg
Flow regimes: constant (CF) and decelerating (dec) at 40, 60 and 80 L/min;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Ventilator setting changes
Intervention Description
Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.
Primary Outcome Measure Information:
Title
Patients' comfort
Description
Borg score of patients' dyspnea
Time Frame
40 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine Manthous, MD
Organizational Affiliation
Bridgeport Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantine Manthous, MD
Phone
203-384-4581
Email
pcmant@bpthosp.org
First Name & Middle Initial & Last Name & Degree
Constantine Manthous, MD
12. IPD Sharing Statement
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Ventilator Settings and Comfort
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