ObesityPhase 3NCT01131390
Ventilator Settings and Comfort
A Phase 3 study testing Ventilator setting changes in people with Obesity and Chronic Obstructive Pulmonary Disease, run by Bridgeport Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Ventilator setting changes
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Constantine Manthous, MD, 203-384-4581, pcmant@bpthosp.org
Constantine Manthous, MD
About this study
Official title: What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.
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.
Read the 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):
- 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.
- Conditions
- Obesity, Chronic Obstructive Pulmonary Disease
- Being tested
- Ventilator setting changes
- Medical subject headings
- Obesity, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator setting changesDevice
Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' comfort
Borg score of patients' dyspnea
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bridgeport Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Constantine Manthous, MD, Principal investigator, Bridgeport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131390
- Sponsor's protocol ID
- Bpthosp11001
- Status last verified
- Mar 2010
- First submitted
- 26 May 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.
- ClinicalTrials.gov ID
- NCT01131390
- Acronym / sponsor ID
- Bpthosp11001
- Conditions
- Obesity, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bridgeport HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (>18 y) admitted to the MICU of Bridgeport Hospital on mechanical ventilation for:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator setting changesVentilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort. | Device | – |
Primary outcome
Patients' comfort
Time frame: 40 minutes
Borg score of patients' dyspnea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine Manthous, MD principal investigator
Bridgeport Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ventilator setting changes in people with Obesity and Chronic Obstructive Pulmonary Disease, run by Bridgeport Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' comfort (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.