Right Ventricular DysfunctionNCT04782154
Paceport Swan-Ganz Data Collection Study
An observational study of Right Ventricular Dysfunction and Right Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction, Right Heart Failure, Congestive Heart Failure
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2021to 1 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years of age, with planned surgery or liver transplantation, projected to receive Swan-Ganz as part of the procedure/standard of care with intermittent cardiac output measures will be screened for inclusion into the Study. Only subjects meeting all inclusion criteria will be enrolled.
Who may be able to join
- Be ≥ 18 years of age
- Participate in the Informed Consent process and sign/date the approved informed consent forms
- Projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures
Who cannot join
- Refuse to sign consent
- Have left bundle branch block
- Have recurrent sepsis
- Have hypercoagulopathy
- Allergic to FORE-SIGHT Elite sensor adhesive
- Latex allergy due to presence of latex in the Swan-Ganz catheter balloon.
Trial locations and contacts
1 site in 1 country.
About this study
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. Our primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.
Read the detailed description
The pulmonary artery catheter (PAC) consists of an intravenous device placed in the pulmonary artery to measure cardiac output, pulmonary artery pressures (Richard C, 2011) as well as cardiac filling pressures. Since its initial presentation by Swan in 1970 (H J Swan, 1970), several modifications were made on the initial catheter now allowing continuous assessment of cardiac output, continuous monitoring of stroke volume (SV), systemic vascular resistance (SVR) and mixed venous saturation (SvO2) (Arora, 2014) (H J Swan, 1970) (Richard C, 2011). We intend to enhance current Swan-Ganz catheters with clinical decision support tools to early identify hemodynamically unstable states that can lead to further deterioration of the patient's health state.
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload (François Haddad, 2008). RV dysfunction can occur in several clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery (François Haddad, 2008). RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients (André Y. Denault, 2006) (Denault AY B. J.-S., 2016). Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described in previous studies: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation have been related to RV dysfunction (Rudski LG, 2010). However, these echocardiographic indices cannot be continuously monitored and are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognized as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation (Raymond M, 2019) (François Haddad, 2008) (Haddad F, 2009). RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system (Naeije R, 2014) (François Haddad, 2008). The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension (Denault AY C. M., 2006). It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.
Since 2002, Dr Denault's group at Montreal Heart Institute has been using continuous RV pressure waveform monitoring initially for the diagnosis of RV outflow tract obstruction (Denault A, 2014) and then for RV diastolic dysfunction evaluation (St-Pierre P, 2014) (Myriam Amsallem, 2016). Preliminary data based on a retrospective study on 259 patients found that 110 (42.5%) patients had abnormal RV gradients before cardiopulmonary bypass (CPB).Abnormal RV diastolic pressure gradient was associated with higher EuroSCORE II (2.29 [1.10-4.78] vs. 1.62 [1.10-3.04], p=0.041), higher incidence of RV diastolic dysfunction using echocardiography (45 % vs. 29 %, p=0.038), higher body mass index (BMI) (27.0 [24.9-30.5] vs. 28.9 [25.5-32.5], p=0.022), pulmonary hypertension (mean pulmonary artery pressure (MPAP) > 25 mmHg) (37 % vs. 48 %, p=0.005) and lower pulmonary artery pulsatility index (PAPi) (1.59 [1.19-2.09] vs. 1.18 [0.92-1.54], p<0.0001). Patients with abnormal RV gradient had more frequent difficult separation from CPB (32 % vs. 19 %, p=0.033) and more often received inhaled pulmonary vasodilator treatment before CPB (50 % vs. 74 %, p<0.001). However, this was retrospective and limited to the pre-CPB period.
In 2017, in a review article on RV failure in the ICU (Hrymak C, 2017), RV pressure waveform monitoring using the paceport of the pulmonary artery catheter was recommended as a simple method of monitoring RV function (Rubenfeld GD, 1999). However, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU.
- Keywords
- Right Ventricular Pressure Waveform
- Medical subject headings
- Ventricular Dysfunction, Right, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg and a RVdP/dt < 400 mmHg.
Measured: From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary outcomes (27)
Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
Difficult separation from cardiopulmonary bypass: instability requiring at least two different types of pharmacological agents (i.e., inotropes ± vasopressors ± inhaled agents) Complex separation from cardiopulmonary bypass: Hemodynamic instability requiring return on cardiopulmonary bypass or addition of mechanical support (intra-aortic balloon pump or extra-corporeal membrane oxygenator)
Measured: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours
Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
TPOD is a continuous variable representative of the burden of care and morbidity during the first 28 days following cardiac surgery and was chosen to circumvent issues arising for using other clinical endpoint such as ICU length of stay
Measured: Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Death from any cause
Measured: Up to 28 days or until hospital discharge
Incidence of acute kidney injury (AKI)
Acute kidney injury (AKI) according to KDIGO serum creatinine criteria: Stage 1: ≥50% or 27 umol/L increases in serum creatinine, Stage 2: ≥100% increase in serum creatinine, Stage 3 ≥200% increase in serum creatinine or an increase to a level of ≥254 umol/L or dialysis initiation.
Measured: Up to 28 days or until hospital discharge
Incidence of major bleeding
Major bleeding is defined by the Bleeding Academic Research Consortium (BARC) as one of the following: • Perioperative intracranial bleeding within 48h • Reoperation after closure of sternotomy for the purpose of controlling bleeding • Transfusion of ≥5 units of whole blood of packed red blood cells within a 48 hours period • Chest tube output ≥2L within a 24 hours period
Measured: Up to 28 days or until hospital discharge
Incidence of surgical reintervention for any reasons
Re-operation after the initial surgery for any cause
Measured: Up to 28 days or until hospital discharge
Incidence of deep sternal wound infection or mediastinitis
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician
Measured: Up to 28 days or until hospital discharge
Incidence of delirium
Delirium is defined as an intensive care delirium screening checklist (ICDSC) score(18) of ≥4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Up to 28 days or until hospital discharge
Incidence of stroke
Central neurologic deficit persisting longer than 72 hours
Measured: Up to 28 days or until hospital discharge
Total duration of ICU stay in hours
Number of hours passed in the ICU
Measured: Up to 28 days or until hospital discharg
Duration of vasopressor requirements (in hours)
Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine
Measured: Up to 28 days or until hospital discharge
Up to 28 days or until hospital discharge
Number of days hospitalized from the day of surgery to discharge
Measured: Up to 28 days or until hospital discharge
Duration of mechanical ventilation (in hours)
A duration of >24 hours will be considered prolonged ventilation requirements.
Measured: Up to 28 days or until hospital discharge
Incidence of major morbidity or mortality
Including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
Measured: Up to 28 days or until hospital discharge
Right ventricular ejection fraction
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular fractional area change
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular strain
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Tricuspid annular plane systolic excursion
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular performance index
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Portal flow pulsatility fraction
Portal flow pulsatility fraction
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular stroke work index
0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)
Measured: From arrival to the operating room until 2 hours after ICU arrival
Relative pulmonary pressure
The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular function index
Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time
Measured: From arrival to the operating room until 2 hours after ICU arrival
Pulmonary artery pulsatility index (PAPi)
Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure
Measured: From arrival to the operating room until 2 hours after ICU arrival
Compliance of the pulmonary artery (CPA)
Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)
Measured: From arrival to the operating room until 2 hours after ICU arrival
Pulsatility of femoral venous flow
Velocity variations of blood flow in the femoral vein during the cardiac cycle
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular outflow tract obstruction
Right Ventricular Systolic pressure minus Pulmonary Artery Systolic pressure ≤ 6 mmHg.
Measured: From arrival to the operating room until 2 hours after ICU arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start9 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Andre Denault, Montreal Heart Institute
- Investigators
- Andre Y Denault, MD,PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782154
- Sponsor's protocol ID
- 2018-20
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Denault AY, Couture P, Buithieu J, Haddad F, Carrier M, Babin D, Levesque S, Tardif JC. Left and right ventricular diastolic dysfunction as predictors of difficult separation from cardiopulmonary bypass. Can J Anaesth. 2006 Oct;53(10):1020-9. doi: 10.1007/BF03022532.
PubMed 16987858Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.
PubMed 25276302Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
PubMed 25432139Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
PubMed 27470232Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.
PubMed 16798301Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.
PubMed 18347220Swan HJ, Ganz W, Forrester J, Marcus H, Diamond G, Chonette D. Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med. 1970 Aug 27;283(9):447-51. doi: 10.1056/NEJM197008272830902. No abstract available.
PubMed 5434111Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
PubMed 19151265Hrymak C, Strumpher J, Jacobsohn E. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management. Can J Cardiol. 2017 Jan;33(1):61-71. doi: 10.1016/j.cjca.2016.10.030. Epub 2016 Nov 11.
PubMed 28024557Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315.
PubMed 27467173Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414.
PubMed 25445946Raymond M, Gronlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25.
PubMed 30269893Richard C, Monnet X, Teboul JL. Pulmonary artery catheter monitoring in 2011. Curr Opin Crit Care. 2011 Jun;17(3):296-302. doi: 10.1097/MCC.0b013e3283466b85.
PubMed 21499096Rubenfeld GD, Angus DC, Pinsky MR, Curtis JR, Connors AF Jr, Bernard GR. Outcomes research in critical care: results of the American Thoracic Society Critical Care Assembly Workshop on Outcomes Research. The Members of the Outcomes Research Workshop. Am J Respir Crit Care Med. 1999 Jul;160(1):358-67. doi: 10.1164/ajrccm.160.1.9807118. No abstract available.
PubMed 10390426Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paceport Swan-Ganz Data Collection Study
- ClinicalTrials.gov ID
- NCT04782154
- Acronym / sponsor ID
- 2018-20
- Keywords
- Right Ventricular Pressure Waveform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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.
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. Our primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.
Detailed description
The pulmonary artery catheter (PAC) consists of an intravenous device placed in the pulmonary artery to measure cardiac output, pulmonary artery pressures (Richard C, 2011) as well as cardiac filling pressures. Since its initial presentation by Swan in 1970 (H J Swan, 1970), several modifications were made on the initial catheter now allowing continuous assessment of cardiac output, continuous monitoring of stroke volume (SV), systemic vascular resistance (SVR) and mixed venous saturation (SvO2) (Arora, 2014) (H J Swan, 1970) (Richard C, 2011). We intend to enhance current Swan-Ganz catheters with clinical decision support tools to early identify hemodynamically unstable states that can lead to further deterioration of the patient's health state.
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload (François Haddad, 2008). RV dysfunction can occur in several clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery (François Haddad, 2008). RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients (André Y. Denault, 2006) (Denault AY B. J.-S., 2016). Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described in previous studies: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation have been related to RV dysfunction (Rudski LG, 2010). However, these echocardiographic indices cannot be continuously monitored and are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognized as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation (Raymond M, 2019) (François Haddad, 2008) (Haddad F, 2009). RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system (Naeije R, 2014) (François Haddad, 2008). The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension (Denault AY C. M., 2006). It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.
Since 2002, Dr Denault's group at Montreal Heart Institute has been using continuous RV pressure waveform monitoring initially for the diagnosis of RV outflow tract obstruction (Denault A, 2014) and then for RV diastolic dysfunction evaluation (St-Pierre P, 2014) (Myriam Amsallem, 2016). Preliminary data based on a retrospective study on 259 patients found that 110 (42.5%) patients had abnormal RV gradients before cardiopulmonary bypass (CPB).Abnormal RV diastolic pressure gradient was associated with higher EuroSCORE II (2.29 [1.10-4.78] vs. 1.62 [1.10-3.04], p=0.041), higher incidence of RV diastolic dysfunction using echocardiography (45 % vs. 29 %, p=0.038), higher body mass index (BMI) (27.0 [24.9-30.5] vs. 28.9 [25.5-32.5], p=0.022), pulmonary hypertension (mean pulmonary artery pressure (MPAP) > 25 mmHg) (37 % vs. 48 %, p=0.005) and lower pulmonary artery pulsatility index (PAPi) (1.59 [1.19-2.09] vs. 1.18 [0.92-1.54], p<0.0001). Patients with abnormal RV gradient had more frequent difficult separation from CPB (32 % vs. 19 %, p=0.033) and more often received inhaled pulmonary vasodilator treatment before CPB (50 % vs. 74 %, p<0.001). However, this was retrospective and limited to the pre-CPB period.
In 2017, in a review article on RV failure in the ICU (Hrymak C, 2017), RV pressure waveform monitoring using the paceport of the pulmonary artery catheter was recommended as a simple method of monitoring RV function (Rubenfeld GD, 1999). However, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years of age, with planned surgery or liver transplantation, projected to receive Swan-Ganz as part of the procedure/standard of care with intermittent cardiac output measures will be screened for inclusion into the Study. Only subjects meeting all inclusion criteria will be enrolled.
Key inclusion criteria (3 listed)
- Be ≥ 18 years of age
- Participate in the Informed Consent process and sign/date the approved informed consent forms
- Projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures
Key exclusion criteria (6 listed)
- Refuse to sign consent
- Have left bundle branch block
- Have recurrent sepsis
- Have hypercoagulopathy
- Allergic to FORE-SIGHT Elite sensor adhesive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
Time frame: From thermodilution catheter insertion until 2 hours after ICU arrival
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg and a RVdP/dt < 400 mmHg.
27 secondary outcomes
Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
Time frame: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours
Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
Time frame: Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Time frame: Up to 28 days or until hospital discharge
Incidence of acute kidney injury (AKI)
Time frame: Up to 28 days or until hospital discharge
Incidence of major bleeding
Time frame: Up to 28 days or until hospital discharge
Incidence of surgical reintervention for any reasons
Time frame: Up to 28 days or until hospital discharge
Incidence of deep sternal wound infection or mediastinitis
Time frame: Up to 28 days or until hospital discharge
Incidence of delirium
Time frame: Up to 28 days or until hospital discharge
Incidence of stroke
Time frame: Up to 28 days or until hospital discharge
Total duration of ICU stay in hours
Time frame: Up to 28 days or until hospital discharg
Duration of vasopressor requirements (in hours)
Time frame: Up to 28 days or until hospital discharge
Up to 28 days or until hospital discharge
Time frame: Up to 28 days or until hospital discharge
Duration of mechanical ventilation (in hours)
Time frame: Up to 28 days or until hospital discharge
Incidence of major morbidity or mortality
Time frame: Up to 28 days or until hospital discharge
Right ventricular ejection fraction
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular fractional area change
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular strain
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Tricuspid annular plane systolic excursion
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular performance index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Portal flow pulsatility fraction
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular stroke work index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Relative pulmonary pressure
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular function index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Pulmonary artery pulsatility index (PAPi)
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Compliance of the pulmonary artery (CPA)
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Pulsatility of femoral venous flow
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular outflow tract obstruction
Time frame: From arrival to the operating room until 2 hours after ICU arrival
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 2 Sep 2022.
- Background: PubMed 16987858Denault AY, Couture P, Buithieu J, Haddad F, Carrier M, Babin D, Levesque S, Tardif JC. Left and right ventricular diastolic dysfunction as predictors of difficult separation from cardiopulmonary bypass. Can J Anaesth. 2006 Oct;53(10):1020-9. doi: 10.1007/BF03022532.
- Background: PubMed 25276302Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.
- Background: PubMed 25432139Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
- Background: PubMed 27470232Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
- Background: PubMed 16798301Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.
- Background: PubMed 18347220Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.
- Background: PubMed 5434111Swan HJ, Ganz W, Forrester J, Marcus H, Diamond G, Chonette D. Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med. 1970 Aug 27;283(9):447-51. doi: 10.1056/NEJM197008272830902. No abstract available.
- Background: PubMed 19151265Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
- Background: PubMed 28024557Hrymak C, Strumpher J, Jacobsohn E. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management. Can J Cardiol. 2017 Jan;33(1):61-71. doi: 10.1016/j.cjca.2016.10.030. Epub 2016 Nov 11.
- Background: PubMed 27467173Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315.
- Background: PubMed 25445946Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414.
- Background: PubMed 30269893Raymond M, Gronlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25.
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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.
Andre Y Denault, MD,PhD principal investigator
Montreal Heart Institute
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 Right Ventricular Dysfunction and Right Heart Failure, run by Montreal Heart Institute 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 3 inclusion and 6 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 2 Sep 2022. 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?
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU (time frame: From thermodilution catheter insertion until 2 hours after ICU arrival). 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 NCT04782154, which also lists 16 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 2 Sep 2022.