Hemodynamically StableNCT02083172
Comparing USCOM and Echocardiographic Hemodynamic Measurements in Children (CUE Study)
An observational study of Hemodynamically Stable and Critical Illness, run by McMaster University at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the agreement between hemodynamic measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in a group of hemodynamically… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hemodynamically Stable, Critical Illness
- What is being tested?
- Ultrasound Cardiac Output Monitor and 2 D-Echo
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jan 2016
- Phase
- Observational
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1. The hemodynamically stable group: will be screened from pediatric in-patients on McMaster Children's Hospital general pediatric wards and those scheduled for elective 2D-echo through cardiology and sedation clinic. 2. The hemodynamically unstable patients and 3. those requiring mechanical ventilation will be screened from McMaster Children's Hospital Pediatric Critical Care Unit.
Who may be able to join
- Age under 18 years
- Patient fulfills clinical criteria for either study cohort
- Most Responsible Physician has ordered an ECHO study on the patient
- Written informed consent by parents/legal guardian/substitute decision maker, and assent where appropriate
- Patients with normal cardiac structure, no pre-existing primary cardiovascular disease or hemodynamically insignificant shunt lesions (i.e. hemodynamically insignificant Atrial Septal Defect/Patent Foramen Oval and Ventricular Septal Defect
Who cannot join
- Age ≥ 18 years
- Premature infants (born <37 weeks gestation) admitted to the Neonatal Intensive Care Unit
- Known co-existing primary cardiac anomalies (i.e. aortic or pulmonary valve stenosis or regurgitation, Aortic Valve regurgitation, shunt lesions save for those mentioned above, and pericardial effusion)
- Prior enrollment in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients
The primary objective of this study is to evaluate the agreement between hemodynamic measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.
Read the detailed description
2D-echo is the standard-of-care tool for non-invasive hemodynamic assessments in children. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. The feasibility of real time hemodynamic assessments is therefore limited with 2D-echo. USCOM has been introduced as a non-invasive bedside hemodynamic monitoring tool that utilizes continuous-wave Doppler ultrasound. As USCOM is easily portable, and measurements take only several minutes and can be conducted by trained physicians or nurses, it has become an attractive method of real time hemodynamic monitoring of unstable patients. While USCOM validation studies have been conducted in adult, neonatal and pediatric populations, the following concerns have been raised: a) Pediatric data on the agreement between USCOM and other standard methods of CO measurement (i.e. 2D-echo, pulmonary artery catheterization) are conflicting with some studies reporting acceptable agreement, while others report poor agreement ; b) USCOM validation and agreement studies were previously conducted in primarily hemodynamically stable populations. Its performance in hemodynamically unstable and mechanically ventilated patients has not been studied to date in the pediatric population.USCOM is currently being promoted as a real-time tool for assessing hemodynamic status, and directing the care of unstable children without adequate evidence. Therefore, this study is essential to inform the validity of USCOM and whether it can or should be used when 2D-echo for real time hemodynamic monitoring in children is not feasible or available.
- Conditions
- Hemodynamically Stable, Critical Illness
- Being tested
- Ultrasound Cardiac Output Monitor and 2 D-Echo
- Keywords
- USCOM (UltraSound Cardiac Output Monitor), 2D echocardiography, agreement, pediatrics
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Cardiac Output Monitor and 2 D-EchoDevice
Also called USCOM
Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamically stable patients | Hemodynamically stable patients will be defined as patients with normal hemodynamic profile as evidenced by normal age-determined vital signs and normal perfusion. Receives: Device: Ultrasound Cardiac Output Monitor and 2 D-Echo | |
| Hemodynamically unstable patients | Hemodynamically unstable patients will be defined as patients who are admitted to the Pediatric Critical Care Unit (PCCU), in whom there is a clinical diagnosis of shock as evidenced by signs and symptoms of hypoperfusion, requiring fluid resuscitation and/or inotropic support. Receives: Device: Ultrasound Cardiac Output Monitor and 2 D-Echo | |
| Mechanically ventilated patients | Patients requiring mechanical ventilation Receives: Device: Ultrasound Cardiac Output Monitor and 2 D-Echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children
Hemodynamic measurements are include cardiac output (CO), Stroke Volume (SV),Aortic cross sectional area (Ao CSA), Preload (SVV%) Inferior Vena cava Collapsibility index (IVC), Inotropy (SMI) and (EF)
Measured: Within 30 minutes of first measurement method
Secondary outcomes (1)
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo, in hemodynamically unstable children, and children receiving positive pressure ventilation respectively
Hemodynamic measurements are include Cardiac Output (CO), Stroke Volume(SV), Preload (SVV%) and IVC collapsibility Index, Inotropy
Measured: Within 30 minutes of first measurement method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Hemodynamically StableStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Choong, McMaster University
- Investigators
- Karen Choong, MD,BCh,MSc, Study chair, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083172
- Sponsor's protocol ID
- 13-658
- Status last verified
- Nov 2015
- First submitted
- 25 Nov 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007 Mar;119(3):487-94. doi: 10.1542/peds.2006-2353.
PubMed 17332201Parrillo JE, Parker MM, Natanson C, Suffredini AF, Danner RL, Cunnion RE, Ognibene FP. Septic shock in humans. Advances in the understanding of pathogenesis, cardiovascular dysfunction, and therapy. Ann Intern Med. 1990 Aug 1;113(3):227-42. doi: 10.7326/0003-4819-113-3-227.
PubMed 2197912Zanotti-Cavazzoni SL, Hollenberg SM. Cardiac dysfunction in severe sepsis and septic shock. Curr Opin Crit Care. 2009 Oct;15(5):392-7. doi: 10.1097/MCC.0b013e3283307a4e.
PubMed 19633546Kumar A, Haery C, Parrillo JE. Myocardial dysfunction in septic shock. Crit Care Clin. 2000 Apr;16(2):251-87. doi: 10.1016/s0749-0704(05)70110-x.
PubMed 10768082Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.
PubMed 19325359Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169Kern JW, Shoemaker WC. Meta-analysis of hemodynamic optimization in high-risk patients. Crit Care Med. 2002 Aug;30(8):1686-92. doi: 10.1097/00003246-200208000-00002.
PubMed 12163777Lapostolle F, Petrovic T, Catineau J, Lenoir G, Adnet F. Training emergency physicians to perform out-of-hospital ultrasonography. Am J Emerg Med. 2005 Jul;23(4):572. doi: 10.1016/j.ajem.2005.01.008. No abstract available.
PubMed 16032640Stewart GM, Nguyen HB, Kim TY, Jauregui J, Hayes SR, Corbett S. Inter-rater reliability for noninvasive measurement of cardiac function in children. Pediatr Emerg Care. 2008 Jul;24(7):433-7. doi: 10.1097/PEC.0b013e31817de143.
PubMed 18580818Meyer S, Todd D, Shadboldt B. Assessment of portable continuous wave Doppler ultrasound (ultrasonic cardiac output monitor) for cardiac output measurements in neonates. J Paediatr Child Health. 2009 Jul-Aug;45(7-8):464-8. doi: 10.1111/j.1440-1754.2009.01535.x.
PubMed 19712182Critchley LA, Peng ZY, Fok BS, Lee A, Phillips RA. Testing the reliability of a new ultrasonic cardiac output monitor, the USCOM, by using aortic flowprobes in anesthetized dogs. Anesth Analg. 2005 Mar;100(3):748-753. doi: 10.1213/01.ANE.0000144774.42408.05.
PubMed 15728064Su BC, Yu HP, Yang MW, Lin CC, Kao MC, Chang CH, Lee WC. Reliability of a new ultrasonic cardiac output monitor in recipients of living donor liver transplantation. Liver Transpl. 2008 Jul;14(7):1029-37. doi: 10.1002/lt.21461.
PubMed 18581505He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9.
PubMed 21933558Brierley J, Peters MJ. Distinct hemodynamic patterns of septic shock at presentation to pediatric intensive care. Pediatrics. 2008 Oct;122(4):752-9. doi: 10.1542/peds.2007-1979.
PubMed 18829798
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02083172
- Acronym / sponsor ID
- 13-658
- Conditions
- Hemodynamically Stable, Critical Illness
- Keywords
- USCOM (UltraSound Cardiac Output Monitor), 2D echocardiography, agreement, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Mar 2014 (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 primary objective of this study is to evaluate the agreement between hemodynamic measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.
Detailed description
2D-echo is the standard-of-care tool for non-invasive hemodynamic assessments in children. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. The feasibility of real time hemodynamic assessments is therefore limited with 2D-echo. USCOM has been introduced as a non-invasive bedside hemodynamic monitoring tool that utilizes continuous-wave Doppler ultrasound. As USCOM is easily portable, and measurements take only several minutes and can be conducted by trained physicians or nurses, it has become an attractive method of real time hemodynamic monitoring of unstable patients. While USCOM validation studies have been conducted in adult, neonatal and pediatric populations, the following concerns have been raised: a) Pediatric data on the agreement between USCOM and other standard methods of CO measurement (i.e. 2D-echo, pulmonary artery catheterization) are conflicting with some studies reporting acceptable agreement, while others report poor agreement ; b) USCOM validation and agreement studies were previously conducted in primarily hemodynamically stable populations. Its performance in hemodynamically unstable and mechanically ventilated patients has not been studied to date in the pediatric population.USCOM is currently being promoted as a real-time tool for assessing hemodynamic status, and directing the care of unstable children without adequate evidence. Therefore, this study is essential to inform the validity of USCOM and whether it can or should be used when 2D-echo for real time hemodynamic monitoring in children is not feasible or available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodynamically stable patients | – | Device: Ultrasound Cardiac Output Monitor and 2 D-EchoHemodynamically stable patients will be defined as patients with normal hemodynamic profile as evidenced by normal age-determined vital signs and normal perfusion. |
| Hemodynamically unstable patients | – | Device: Ultrasound Cardiac Output Monitor and 2 D-EchoHemodynamically unstable patients will be defined as patients who are admitted to the Pediatric Critical Care Unit (PCCU), in whom there is a clinical diagnosis of shock as evidenced by signs and symptoms of hypoperfusion, requiring fluid resuscitation and/or inotropic support. |
| Mechanically ventilated patients | – | Device: Ultrasound Cardiac Output Monitor and 2 D-EchoPatients requiring mechanical ventilation |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1. The hemodynamically stable group: will be screened from pediatric in-patients on McMaster Children's Hospital general pediatric wards and those scheduled for elective 2D-echo through cardiology and sedation clinic. 2. The hemodynamically unstable patients and 3. those requiring mechanical ventilation will be screened from McMaster Children's Hospital Pediatric Critical Care Unit.
Key inclusion criteria (5 listed)
- Age under 18 years
- Patient fulfills clinical criteria for either study cohort
- Most Responsible Physician has ordered an ECHO study on the patient
- Written informed consent by parents/legal guardian/substitute decision maker, and assent where appropriate
- Patients with normal cardiac structure, no pre-existing primary cardiovascular disease or hemodynamically insignificant shunt lesions (i.e. hemodynamically insignificant Atrial Septal Defect/Patent Foramen Oval and Ventricular Septal Defect
Key exclusion criteria (4 listed)
- Age ≥ 18 years
- Premature infants (born <37 weeks gestation) admitted to the Neonatal Intensive Care Unit
- Known co-existing primary cardiac anomalies (i.e. aortic or pulmonary valve stenosis or regurgitation, Aortic Valve regurgitation, shunt lesions save for those mentioned above, and pericardial effusion)
- Prior enrollment in study
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 |
|---|---|---|
| Ultrasound Cardiac Output Monitor and 2 D-EchoAlso: USCOMHemodynamic measurements obtained by 2D-Echo and USCOM will be compared. | Device | Hemodynamically stable patients, Hemodynamically unstable patients, Mechanically ventilated patients |
Primary outcome
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children
Time frame: Within 30 minutes of first measurement method
Hemodynamic measurements are include cardiac output (CO), Stroke Volume (SV),Aortic cross sectional area (Ao CSA), Preload (SVV%) Inferior Vena cava Collapsibility index (IVC), Inotropy (SMI) and (EF)
1 secondary outcome
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo, in hemodynamically unstable children, and children receiving positive pressure ventilation respectively
Time frame: Within 30 minutes of first measurement method
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 16 Mar 2016.
- Background: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
- Background: PubMed 17332201Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007 Mar;119(3):487-94. doi: 10.1542/peds.2006-2353.
- Background: PubMed 2197912Parrillo JE, Parker MM, Natanson C, Suffredini AF, Danner RL, Cunnion RE, Ognibene FP. Septic shock in humans. Advances in the understanding of pathogenesis, cardiovascular dysfunction, and therapy. Ann Intern Med. 1990 Aug 1;113(3):227-42. doi: 10.7326/0003-4819-113-3-227.
- Background: PubMed 19633546Zanotti-Cavazzoni SL, Hollenberg SM. Cardiac dysfunction in severe sepsis and septic shock. Curr Opin Crit Care. 2009 Oct;15(5):392-7. doi: 10.1097/MCC.0b013e3283307a4e.
- Background: PubMed 10768082Kumar A, Haery C, Parrillo JE. Myocardial dysfunction in septic shock. Crit Care Clin. 2000 Apr;16(2):251-87. doi: 10.1016/s0749-0704(05)70110-x.
- Background: PubMed 19325359Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Background: PubMed 12163777Kern JW, Shoemaker WC. Meta-analysis of hemodynamic optimization in high-risk patients. Crit Care Med. 2002 Aug;30(8):1686-92. doi: 10.1097/00003246-200208000-00002.
- Background: PubMed 16032640Lapostolle F, Petrovic T, Catineau J, Lenoir G, Adnet F. Training emergency physicians to perform out-of-hospital ultrasonography. Am J Emerg Med. 2005 Jul;23(4):572. doi: 10.1016/j.ajem.2005.01.008. No abstract available.
- Background: PubMed 18580818Stewart GM, Nguyen HB, Kim TY, Jauregui J, Hayes SR, Corbett S. Inter-rater reliability for noninvasive measurement of cardiac function in children. Pediatr Emerg Care. 2008 Jul;24(7):433-7. doi: 10.1097/PEC.0b013e31817de143.
- Background: PubMed 19712182Meyer S, Todd D, Shadboldt B. Assessment of portable continuous wave Doppler ultrasound (ultrasonic cardiac output monitor) for cardiac output measurements in neonates. J Paediatr Child Health. 2009 Jul-Aug;45(7-8):464-8. doi: 10.1111/j.1440-1754.2009.01535.x.
- Background: PubMed 15728064Critchley LA, Peng ZY, Fok BS, Lee A, Phillips RA. Testing the reliability of a new ultrasonic cardiac output monitor, the USCOM, by using aortic flowprobes in anesthetized dogs. Anesth Analg. 2005 Mar;100(3):748-753. doi: 10.1213/01.ANE.0000144774.42408.05.
Related trials for Hemodynamically Stable
Not yet recruiting
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief
Not yet recruitingPhase 4
Comparing Two Heart Medicines for Fast, Irregular Heartbeat (Atrial Fibrillation)
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Active, not recruiting
Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization
Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients
RecruitingObservational study
Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
Pain Management, Critical Illness
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.
Karen Choong, MD,BCh,MSc study chair
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamically Stable and Critical Illness, run by McMaster University at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 Canada. 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.
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?
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children (time frame: Within 30 minutes of first measurement method). 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 NCT02083172, which also lists 41 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 16 Mar 2016.