Coronary Artery DiseasePhase 2NO-NUMONCT00581399
A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
A Phase 2 study testing NO-NUMO™ High Vacuum Body Cavity Drainage System and PVC Chest Tube in people with Coronary Artery Disease and Heart Valve Disease, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Valve Disease
- What is being tested?
- NO-NUMO™ High Vacuum Body Cavity Drainage System and PVC Chest Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or Female 18 year-old or older
- Patients undergoing open heart surgery by means of a standard cardiopulmonary bypass
- The surgical procedures accepted include:
- Coronary-artery-bypass grafting
- Valve replacement or repair, or a combination of both
- Excision of a left ventricular aneurysm
Show all 11Show fewer
- Bentall procedure is included but we do not include those undergoing replacement of the aortic arch aneurysm, utilizing deep hypothermic circulatory arrest.
- We include both first time operation and re-do operations.
- Patients with insulin dependent diabetes mellitus are included. Those with chronic renal failure who are on a hemodialysis treatment will be included.
- Emergency CABG for unstable angina following acute myocardial infarction
- Patients must agreed to participate and sign an Informed Consent Form before the surgical procedure
Who cannot join
- Transmyocardial laser revascularization
- Open heart surgery for congenital heart diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: A Prospective, Randomized, Multicenter Clinical Study on the High Vacuum Body Cavity Drainage Systems Following Open Heart Surgery
The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery. This is less painful to the patient and should help the patient to breathe better after operation. Preliminary data suggests that the high vacuum suction is effective and practical, and could actually reduce the amount of chest tube bleeding after surgery without compromising heart function. This new high vacuum drainage system was approved by the FDA in 2002. Subsequent testing at University of California, Irvine indicated that this unique system may allow the surgeon to predict excessive postoperative bleeding before the patient is transferred out of the operating room, thus adding safety, convenience, and cost effectiveness to their use.
Read the detailed description
High vacuum chest drainage was once considered inadvisable because of a possible suction injury to soft tissues, such as the lungs or mediastinum. Wakabayashi showed that excessive suction force generated by a high vacuum pressure was related to the surface area of the suction applied to the tissues and not the vacuum pressure itself1\&2. He postulated that suction injury to the lung would not occur if the suction force of a chest tube is below the capillary blood pressure of 30 - 35 torr2. Based on this theory, Wakabayashi developed a double-lumen chest drainage tube3 (Trade name NO-NUMO™) and its clinical use was approved by FDA4 in 2002. A prototype 7-5Fr double-lumen chest tube was successfully tested in laboratory animals and three patients1\&2 and the safety of high vacuum chest drainage was proven in a large number of patients undergoing uncomplicated thoracoscopic surgeries2. The unique design of the new drainage tube is the small diameter double lumen tube with hundreds of tiny holes that allows rapid drainage without damaging effects of high suction over a limited surface area. High vacuum suction is available on wall units already in place in the OR and ICU beds. To adopt this system for clinical use, a high vacuum gauge was needed (most don't go beyond 200 torr) to monitor suction, and a high pressure battery powered vacuum pump for transport was necessary, so that drainage was maintained and blood clotting in the tube avoided during the period of prolonged transport from the OR and the setup in the ICU. Several brands of portable vacuum pumps on the market were evaluated before concluding that the Vario™ pump (Medela® Inc.) was superior. The maximal vacuum pressure that Vario pump can generate is 630 torr or 84 kPa which is equivalent to -857 cmH2O.
The NO-NUMO™ High Vacuum Body Cavity Drainage System consist of; (1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump. We evaluated this new system, using a 13Fr triple-tube set for the mediastinal drainage, a 13Fr single-tube for the left pleural drainage and two 13Fr NO-NUMO tubes for the drainage of the lower extremity subcutaneous wounds following the harvesting of the saphenous veins. The tubing was connected to a disposable liner of a Medi-Vac™ (Cardinal Health, Inc.) suction canisters, which was connected to a Vario pump at 300 torr (= 40 kPa) in patients following open heart surgeries.
- Conditions
- Coronary Artery Disease, Heart Valve Disease
- Being tested
- NO-NUMO™ High Vacuum Body Cavity Drainage System, PVC Chest Tube
- Keywords
- Open heart surgery, Cardiopulmonary Bypass, Coronary Artery Bypass Grafting, Chest Tube, Valve Replacement, Valve Repair
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO-NUMO™ High Vacuum Body Cavity Drainage SystemDevice
(1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump
PVC Chest TubeDevice
Standard PVC Chest Tube Sizes 14-36 French
| Study group | Role | What they receive |
|---|---|---|
| NO-NUMO Chest Tube | Experimental | The NO-NUMO™ High Vacuum Body Cavity Drainage System consist of disposable NO-NUMO™ body cavity drainage tubes, disposable Vario™ fluid management canisters Vario™ portable vacuum pump Receives: Device: NO-NUMO™ High Vacuum Body Cavity Drainage System |
| Standard Chest Tube | Active comparator | Classic PVC Chest Tube Receives: Device: PVC Chest Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Postoperative Bleeding
The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.
Measured: 24-48 hours post surgery
Secondary outcomes (1)
Duration of Mediastinal Drainage
The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.
Measured: Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey C Milliken, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581399
- Sponsor's protocol ID
- hs#2006-5196
- Acronym
- NO-NUMO
- Status last verified
- Oct 2011
- First submitted
- 20 Dec 2007
- Last updated
- 31 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Clinical Study on the High Vacuum Body Cavity Drainage Systems Following Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00581399
- Acronym / sponsor ID
- NO-NUMO / hs#2006-5196
- Conditions
- Coronary Artery Disease, Heart Valve Disease
- Keywords
- Open heart surgery, Cardiopulmonary Bypass, Coronary Artery Bypass Grafting, Chest Tube, Valve Replacement, Valve Repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 31 Oct 2011
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 compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery. This is less painful to the patient and should help the patient to breathe better after operation. Preliminary data suggests that the high vacuum suction is effective and practical, and could actually reduce the amount of chest tube bleeding after surgery without compromising heart function. This new high vacuum drainage system was approved by the FDA in 2002. Subsequent testing at University of California, Irvine indicated that this unique system may allow the surgeon to predict excessive postoperative bleeding before the patient is transferred out of the operating room, thus adding safety, convenience, and cost effectiveness to their use.
Detailed description
High vacuum chest drainage was once considered inadvisable because of a possible suction injury to soft tissues, such as the lungs or mediastinum. Wakabayashi showed that excessive suction force generated by a high vacuum pressure was related to the surface area of the suction applied to the tissues and not the vacuum pressure itself1\&2. He postulated that suction injury to the lung would not occur if the suction force of a chest tube is below the capillary blood pressure of 30 - 35 torr2. Based on this theory, Wakabayashi developed a double-lumen chest drainage tube3 (Trade name NO-NUMO™) and its clinical use was approved by FDA4 in 2002. A prototype 7-5Fr double-lumen chest tube was successfully tested in laboratory animals and three patients1\&2 and the safety of high vacuum chest drainage was proven in a large number of patients undergoing uncomplicated thoracoscopic surgeries2. The unique design of the new drainage tube is the small diameter double lumen tube with hundreds of tiny holes that allows rapid drainage without damaging effects of high suction over a limited surface area. High vacuum suction is available on wall units already in place in the OR and ICU beds. To adopt this system for clinical use, a high vacuum gauge was needed (most don't go beyond 200 torr) to monitor suction, and a high pressure battery powered vacuum pump for transport was necessary, so that drainage was maintained and blood clotting in the tube avoided during the period of prolonged transport from the OR and the setup in the ICU. Several brands of portable vacuum pumps on the market were evaluated before concluding that the Vario™ pump (Medela® Inc.) was superior. The maximal vacuum pressure that Vario pump can generate is 630 torr or 84 kPa which is equivalent to -857 cmH2O.
The NO-NUMO™ High Vacuum Body Cavity Drainage System consist of; (1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump. We evaluated this new system, using a 13Fr triple-tube set for the mediastinal drainage, a 13Fr single-tube for the left pleural drainage and two 13Fr NO-NUMO tubes for the drainage of the lower extremity subcutaneous wounds following the harvesting of the saphenous veins. The tubing was connected to a disposable liner of a Medi-Vac™ (Cardinal Health, Inc.) suction canisters, which was connected to a Vario pump at 300 torr (= 40 kPa) in patients following open heart surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO-NUMO Chest Tube | Experimental | Device: NO-NUMO™ High Vacuum Body Cavity Drainage SystemThe NO-NUMO™ High Vacuum Body Cavity Drainage System consist of disposable NO-NUMO™ body cavity drainage tubes, disposable Vario™ fluid management canisters Vario™ portable vacuum pump |
| Standard Chest Tube | Active comparator | Device: PVC Chest TubeClassic PVC Chest Tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female 18 year-old or older
- Patients undergoing open heart surgery by means of a standard cardiopulmonary bypass
- The surgical procedures accepted include:
- Patients must agreed to participate and sign an Informed Consent Form before the surgical procedure
Key exclusion criteria (2 listed)
- Transmyocardial laser revascularization
- Open heart surgery for congenital heart diseases.
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 |
|---|---|---|
| NO-NUMO™ High Vacuum Body Cavity Drainage System(1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump | Device | NO-NUMO Chest Tube |
| PVC Chest TubeStandard PVC Chest Tube Sizes 14-36 French | Device | Standard Chest Tube |
Primary outcome
Amount of Postoperative Bleeding
Time frame: 24-48 hours post surgery
The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.
1 secondary outcome
Duration of Mediastinal Drainage
Time frame: Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey C Milliken, MD principal investigator
University of California, Irvine
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 NO-NUMO™ High Vacuum Body Cavity Drainage System and PVC Chest Tube in people with Coronary Artery Disease and Heart Valve Disease, run by University of California, Irvine 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 11 inclusion and 2 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: finished, as of the sponsor's last update on 31 Oct 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 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?
Yes. Results are posted in the registry (first posted 31 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Postoperative Bleeding (time frame: 24-48 hours post surgery). 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 31 Oct 2011.