Recruiting
Phase 3

Observational Study

Sponsor:

Bridgeport Hospital

Code:

NCT01131390

Conditions

Obesity

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ventilator setting changes

Study Details

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.

Conditions

Obesity

Chronic Obstructive Pulmonary Disease

Study ID

NCT01131390

Start date

Mar, 2010

Status verified date

Mar, 2010

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

Ventilator setting changes

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

Primary outcome measure

  • Patients' comfort [ Time Frame: 40 minutes ]

Central Contacts and Locations

Locations

Bridgeport Hospital

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Constantine Manthous, MD

203-384-4581pcmant@bpthosp.org

Principal Investigator:

Constantine Manthous, MD

More Information

Sponsor

Bridgeport Hospital

Last update posted

Jun 22, 2011

Last verified

Mar, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bridgeport Hospital on 2011-06-22.