NCT01131390

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

March 1, 2010

Enrollment Period

1.8 years

First QC Date

May 26, 2010

Last Update Submit

June 21, 2011

Conditions

ObesityChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Patients' comfort

    Borg score of patients' dyspnea

    40 minutes

Interventions

Ventilator setting changesDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

RECRUITING

MeSH Terms

Conditions

ObesityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Constantine Manthous, MD

    Bridgeport Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 22, 2011

Record last verified: 2010-03

Locations

US(1)