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Ventilator Settings and Comfort

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ClinicalTrials.gov Identifier: NCT01131390
Recruitment Status : Unknown
Verified March 2010 by Bridgeport Hospital.
Recruitment status was:  Recruiting
First Posted : May 27, 2010
Last Update Posted : June 22, 2011
Information provided by:
Bridgeport Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Chronic Obstructive Pulmonary Disease Device: Ventilator setting changes Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.
Study Start Date : March 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Intervention Details:
    Device: Ventilator setting changes
    Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.

Primary Outcome Measures :
  1. Patients' comfort [ Time Frame: 40 minutes ]
    Borg score of patients' dyspnea

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131390

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         
Sponsors and Collaborators
Bridgeport Hospital
Principal Investigator: Constantine Manthous, MD Bridgeport Hospital

Responsible Party: Constantine A. Manthous, MD, Bridgeport Hospital
ClinicalTrials.gov Identifier: NCT01131390     History of Changes
Other Study ID Numbers: Bpthosp11001
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: March 2010

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Nutrition Disorders
Body Weight
Signs and Symptoms
Respiratory Tract Diseases