Critical IllnessPhase 2NAV-1NCT00468247
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System
A Phase 2 study testing Navigator and Conventional care in people with Critical Illness and Intensive Care, run by Applied Physiology Pty Ltd at 7 sites in Australia.
Trial summary
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care
- What is being tested?
- Navigator and Conventional care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 7 sitesAustralia
- Study dates
- Mar 2007to Apr 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older
- Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
- Will have an arterial line and Swan Ganz catheter in situ
- Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
- Are able and willing to provide written informed consent to participate in the study
Who cannot join
- Women who are lactating or pregnant
- Require Extracorporeal Membrane Oxygenation
- Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
- Intra-operative surgical treatment for atrial fibrillation
- Surgery for left atrial reduction
- Patients with left ventricular assist devices
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- Patients with permanent pacemakers in situ
- Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial
- Have a medical condition that in the opinion of the investigator would jeopardise the patient's safety by participating in this trial
- Current participation in another drug or device study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Monash Medical Centre
Melbourne, Victoria, 3168
The Alfred Hospital
Melbourne, Victoria, 3181
St Vincent's Public Hospital
Sydney, New South Wales, 2010
Royal North Shore Hospital
Sydney, New South Wales, 2065
Westmead Private Hospital
Sydney, New South Wales, 2145
Westmead Public Hospital
Sydney, New South Wales, 2145
St George Public Hospital
Sydney, New South Wales, 2217
About this study
Official title: A Prospective,Open,Multicentre,RCT to Assess the Safety & Efficacy of Navigator v Conventional Care in Post-op Cardiac Surgery Patients Undergoing CABG &/or Heart Valve Repair/Replacement Utilising Heart Lung Perfusion Pump(The NAV-1 Study)
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. The purpose of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by the Navigator guided circulatory management system provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an Intensive Care Unit setting.
Read the detailed description
Protocol No. AP2006-01
Study title: A Prospective, Open, Randomised, Multicentre, Controlled Group Study to Assess the Safety and Efficacy of Navigator versus Conventional Care in Postoperative Cardiac Surgery Patients Undergoing Coronary Bypass Grafting and or Heart Valve Repair or Replacement Utilizing Heart Lung Perfusion Pump.
Acronym: NAV 1
Type of study: Device Trial
Sponsor: Applied Physiology Pty Ltd
Study device: Navigator Guided Circulatory Care Management System
Route of Administration: Via Touch Panel Computer, externally connected to the bedside physiological monitor in a critical care environment
Study centres: Six Australian centres
Study design: Multicentre, open, randomised, controlled group study
Total sample size: One hundred completed patients, 50 in each arm
Study population: Post operative coronary bypass and heart valve repair or replacement patients admitted to a Cardiac Intensive Care or Intensive Care Unit. Surgery must involve the use of a heart lung perfusion pump and the patient must have a functioning arterial line and Swan Ganz catheter in situ to enable the measurement of Cardiac Output, Mean Arterial Pressure, and Right Atrial Pressure.
Study regimen: Following surgery, and after meeting inclusion and exclusion criteria, patients will be randomised on admission to ICU to receive care guided by Navigator or conventional care during their ICU stay while CO is being monitored. All patients will be connected to the Navigator; the screen of the patients in the control group will have the graphical section blank, the right hand side will display actual values of MAP, CO and RAP as slaved from the bedside monitor, along with the patient's screening and randomisation number and initials. The arm of the study to which the patient has been randomised ;control/Navigator, will also be shown.
Endpoints:
Primary: The primary efficacy endpoint is the average distance to the central point of the target cardiovascular zone over the period the patient is connected to Navigator.
Secondary: Secondary endpoints for the trial will be:
- Percentage time in the target cardiovascular zone over the period the patient is connected to the Navigator
- Clinically significant atrial fibrillation over the period the patient is connected to the Navigator. This is defined as irregular supraventricular rhythm with an absence of discrete P waves lasting more than ten minutes documented and confirmed with an ECG
- Multiple organ function, as assessed using the SOFA score, calculated daily
- Navigator device related adverse events and device failures
Statistical analysis: The primary and secondary endpoints and all safety data will be analysed on the randomised Intention-to-treat population.The ITT population will include all individuals who are randomised. The analysis will compare the primary efficacy endpoint between the two randomised treatment groups using independent t tests. The secondary analyses will compare the secondary endpoints between the two randomised treatment groups using independent t-tests, Chi-square tests and Fisher's exact tests as appropriate.
Study Period: From the first pre-surgery screening visit to the post operative follow up visit, approximately six weeks
- Conditions
- Critical Illness, Intensive Care
- Being tested
- Navigator, Conventional care
- Keywords
- mean systemic pressure, fluid therapy, closed loop control, circulation modelling
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigatorDevice
Navigator circulatory mgt system
Conventional careOther
Conventional haemodynamic care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Device , Navigator used for guiding haemodynamic care Receives: Device: Navigator |
| 2 | Placebo comparator | Conventional care Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average distance to central point of the target cardiovascular zone while connected to the device
Measured: Time connected to Navigator device
Secondary outcomes (4)
Percentage time in the target cardiovascular zone while connected to device
Measured: Time connected to Navigator device
Clinically significant AF while connected to device
Measured: Time connected to Navigator device
Multiple organ function (SOFA score)
Measured: From connection to Navigator device to hospital discharge
Device-related adverse events and device failures
Measured: Time connected to Navigator device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Physiology Pty Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Trident Clinical Research Pty Ltd
- Investigators
- Yugan Mudaliar, PhD, Principal investigator, Western Sydney Area Health ServiceGeoff Parkin, PhD, Study director, Monash Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468247
- Sponsor's protocol ID
- AP2006-01
- Acronym
- NAV-1
- Status last verified
- Apr 2008
- First submitted
- 30 Apr 2007
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.
PubMed 16603021Pellegrino VA, Mudaliar Y, Gopalakrishnan M, Horton MD, Killick CJ, Parkin WG, Playford HR, Raper RF. Computer based haemodynamic guidance system is effective and safe in management of postoperative cardiac surgery patients. Anaesth Intensive Care. 2011 Mar;39(2):191-201. doi: 10.1177/0310057X1103900207.
PubMed 21485666
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Open,Multicentre,RCT to Assess the Safety & Efficacy of Navigator v Conventional Care in Post-op Cardiac Surgery Patients Undergoing CABG &/or Heart Valve Repair/Replacement Utilising Heart Lung Perfusion Pump(The NAV-1 Study)
- ClinicalTrials.gov ID
- NCT00468247
- Acronym / sponsor ID
- NAV-1 / AP2006-01
- Conditions
- Critical Illness, Intensive Care
- Keywords
- mean systemic pressure, fluid therapy, closed loop control, circulation modelling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Applied Physiology Pty LtdUniversity, hospital or other
- Collaborators
- Trident Clinical Research Pty Ltd
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 May 2007 (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.
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. The purpose of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by the Navigator guided circulatory management system provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an Intensive Care Unit setting.
Detailed description
Protocol No. AP2006-01
Study title: A Prospective, Open, Randomised, Multicentre, Controlled Group Study to Assess the Safety and Efficacy of Navigator versus Conventional Care in Postoperative Cardiac Surgery Patients Undergoing Coronary Bypass Grafting and or Heart Valve Repair or Replacement Utilizing Heart Lung Perfusion Pump.
Acronym: NAV 1
Type of study: Device Trial
Sponsor: Applied Physiology Pty Ltd
Study device: Navigator Guided Circulatory Care Management System
Route of Administration: Via Touch Panel Computer, externally connected to the bedside physiological monitor in a critical care environment
Study centres: Six Australian centres
Study design: Multicentre, open, randomised, controlled group study
Total sample size: One hundred completed patients, 50 in each arm
Study population: Post operative coronary bypass and heart valve repair or replacement patients admitted to a Cardiac Intensive Care or Intensive Care Unit. Surgery must involve the use of a heart lung perfusion pump and the patient must have a functioning arterial line and Swan Ganz catheter in situ to enable the measurement of Cardiac Output, Mean Arterial Pressure, and Right Atrial Pressure.
Study regimen: Following surgery, and after meeting inclusion and exclusion criteria, patients will be randomised on admission to ICU to receive care guided by Navigator or conventional care during their ICU stay while CO is being monitored. All patients will be connected to the Navigator; the screen of the patients in the control group will have the graphical section blank, the right hand side will display actual values of MAP, CO and RAP as slaved from the bedside monitor, along with the patient's screening and randomisation number and initials. The arm of the study to which the patient has been randomised ;control/Navigator, will also be shown.
Endpoints:
Primary: The primary efficacy endpoint is the average distance to the central point of the target cardiovascular zone over the period the patient is connected to Navigator.
Secondary: Secondary endpoints for the trial will be:
- Percentage time in the target cardiovascular zone over the period the patient is connected to the Navigator
- Clinically significant atrial fibrillation over the period the patient is connected to the Navigator. This is defined as irregular supraventricular rhythm with an absence of discrete P waves lasting more than ten minutes documented and confirmed with an ECG
- Multiple organ function, as assessed using the SOFA score, calculated daily
- Navigator device related adverse events and device failures
Statistical analysis: The primary and secondary endpoints and all safety data will be analysed on the randomised Intention-to-treat population.The ITT population will include all individuals who are randomised. The analysis will compare the primary efficacy endpoint between the two randomised treatment groups using independent t tests. The secondary analyses will compare the secondary endpoints between the two randomised treatment groups using independent t-tests, Chi-square tests and Fisher's exact tests as appropriate.
Study Period: From the first pre-surgery screening visit to the post operative follow up visit, approximately six weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: NavigatorDevice , Navigator used for guiding haemodynamic care |
| 2 | Placebo comparator | Other: Conventional careConventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 years or older
- Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
- Will have an arterial line and Swan Ganz catheter in situ
- Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
- Are able and willing to provide written informed consent to participate in the study
Key exclusion criteria (10 listed)
- Women who are lactating or pregnant
- Require Extracorporeal Membrane Oxygenation
- Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
- Intra-operative surgical treatment for atrial fibrillation
- Surgery for left atrial reduction
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 |
|---|---|---|
| NavigatorNavigator circulatory mgt system | Device | 1 |
| Conventional careConventional haemodynamic care | Other | 2 |
Primary outcome
Average distance to central point of the target cardiovascular zone while connected to the device
Time frame: Time connected to Navigator device
4 secondary outcomes
Percentage time in the target cardiovascular zone while connected to device
Time frame: Time connected to Navigator device
Clinically significant AF while connected to device
Time frame: Time connected to Navigator device
Multiple organ function (SOFA score)
Time frame: From connection to Navigator device to hospital discharge
Device-related adverse events and device failures
Time frame: Time connected to Navigator device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
- Background: PubMed 16603021Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.
- Derived from this study: PubMed 21485666Pellegrino VA, Mudaliar Y, Gopalakrishnan M, Horton MD, Killick CJ, Parkin WG, Playford HR, Raper RF. Computer based haemodynamic guidance system is effective and safe in management of postoperative cardiac surgery patients. Anaesth Intensive Care. 2011 Mar;39(2):191-201. doi: 10.1177/0310057X1103900207.
- Related InfoLink provided by the sponsor.
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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.
Yugan Mudaliar, PhD principal investigator
Western Sydney Area Health Service
Geoff Parkin, PhD study director
Monash Medical Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navigator and Conventional care in people with Critical Illness and Intensive Care, run by Applied Physiology Pty Ltd at 7 sites in Australia.
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 10 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 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average distance to central point of the target cardiovascular zone while connected to the device (time frame: Time connected to Navigator device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468247, which also lists 2 linked publications.
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 25 Apr 2008.