Ventilator Settings and Comfort

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Bridgeport Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bridgeport Hospital
ClinicalTrials.gov Identifier:
NCT01131390
First received: May 26, 2010
Last updated: June 21, 2011
Last verified: March 2010
  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.

Resource links provided by NLM:


Further study details as provided by Bridgeport Hospital:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131390

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         
Sponsors and Collaborators
Bridgeport Hospital
Investigators
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 July 22, 2014