Ventilator Settings and Comfort
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Chronic Obstructive Pulmonary Disease |
Device: Ventilator setting changes |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity. |
- Patients' comfort [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]Borg score of patients' dyspnea
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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Device: Ventilator setting changes
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Connecticut | |
| Bridgeport Hospital | Recruiting |
| Bridgeport, Connecticut, United States, 06610 | |
| Contact: Constantine Manthous, MD 203-384-4581 pcmant@bpthosp.org | |
| Principal Investigator: Constantine Manthous, MD | |
| Principal Investigator: | Constantine Manthous, MD | Bridgeport Hospital |
More Information
No publications provided
| Responsible Party: | Constantine A. Manthous, MD, Bridgeport Hospital |
| ClinicalTrials.gov Identifier: | NCT01131390 History of Changes |
| Other Study ID Numbers: | Bpthosp11001 |
| Study First Received: | May 26, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Obesity Lung Diseases, Obstructive Respiratory Tract Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013