Mechanical VentilationPhase 2RESCUENCT00663637
Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
A Phase 2 study testing CAM (Complete Airway Management) Catheters in people with Mechanical Ventilation and Pneumonia, run by O. M. Neotech, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Ventilation, Pneumonia
- What is being tested?
- CAM (Complete Airway Management) Catheters
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to not given
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving medical care in adult intensive care unit setting
- Patients who have been intubated and mechanically ventilated for at least 12 hours
- Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater
Who cannot join
- Patients receiving medical care in a setting not compatible with an adult intensive care unit
- Patients who have been intubated and mechanically ventilated for less than 12 hours
- Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
- Patients intubated with dual lumen or steel-reinforced endotracheal tubes
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Robert H. Stone, RRT
Stephen S. Bricknell, RRT
About this study
Official title: Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).
Read the detailed description
Thirty mechanically ventilated adult patients will be managed with standard suction catheters. Just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. The endotracheal tubes will then be cleaned using the CAM Catheters (Rescue Cath followed by Endotrach Cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.
- Conditions
- Mechanical Ventilation, Pneumonia
- Being tested
- CAM (Complete Airway Management) Catheters
- Keywords
- endotracheal tube obstruction, occlusion, mechanical ventilation, complication, work of breathing, airway resistance, secretions, pneumonia, ventilator associated, biofilms, endotracheal tube
- Medical subject headings
- Pneumonia, Bites and Stings, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM (Complete Airway Management) CathetersDevice
Also called CAM Rescue Cath, CAM Endotrach Cath
Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.
What is being measured
The primary outcome is the main question the study is designed to answer.
work of breathing
Measured: pre-extubation
Secondary outcomes (1)
endotracheal tube patency
Measured: pre-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- O. M. Neotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Saint Francis Medical Center, Statistical Consulting
- Investigators
- Orlando V. Morejon, MD, Study director, Saint Francis Medical Center; Omneotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663637
- Sponsor's protocol ID
- CAM-0801
- Acronym
- RESCUE
- Status last verified
- Apr 2008
- First submitted
- 18 Apr 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study
- ClinicalTrials.gov ID
- NCT00663637
- Acronym / sponsor ID
- RESCUE / CAM-0801
- Conditions
- Mechanical Ventilation, Pneumonia
- Keywords
- endotracheal tube obstruction, occlusion, mechanical ventilation, complication, work of breathing, airway resistance, secretions, pneumonia, ventilator associated, biofilms, endotracheal tube
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- O. M. Neotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Saint Francis Medical Center, Statistical Consulting
- Study start
- Apr 2008
- First posted
- 22 Apr 2008 (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.
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).
Detailed description
Thirty mechanically ventilated adult patients will be managed with standard suction catheters. Just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. The endotracheal tubes will then be cleaned using the CAM Catheters (Rescue Cath followed by Endotrach Cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving medical care in adult intensive care unit setting
- Patients who have been intubated and mechanically ventilated for at least 12 hours
- Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater
Key exclusion criteria (4 listed)
- Patients receiving medical care in a setting not compatible with an adult intensive care unit
- Patients who have been intubated and mechanically ventilated for less than 12 hours
- Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
- Patients intubated with dual lumen or steel-reinforced endotracheal tubes
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 |
|---|---|---|
| CAM (Complete Airway Management) CathetersAlso: CAM Rescue Cath, CAM Endotrach CathPrior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath. | Device | – |
Primary outcome
work of breathing
Time frame: pre-extubation
1 secondary outcome
endotracheal tube patency
Time frame: pre-extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
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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.
Orlando V. Morejon, MD study director
Saint Francis Medical Center; Omneotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAM (Complete Airway Management) Catheters in people with Mechanical Ventilation and Pneumonia, run by O. M. Neotech, Inc. 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 3 inclusion and 4 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 29 May 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Robert H. Stone, RRT (573-331-3000 ext. 6393, bstone@sfmc.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
work of breathing (time frame: pre-extubation). 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 29 May 2008.