Paceport Swan-Ganz Data Collection Study

Congestive Heart Failure Clinical Trial

Official title:

Paceport Swan-Ganz Data Collection Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782154
• Other study ID #: 2018-20
• Status: Completed
• Start date: August 9, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: August 2022
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Right Heart Failure
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Edwards Lifesciences

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Amsallem 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. Review. — View Citation

Denault 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. Review. — View Citation

Denault AY, Bussières JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQ, 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):1140-53. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28. — View Citation

Denault AY, Chaput M, Couture P, Hébert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. — View Citation

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. — View Citation

Haddad 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. Review. — View Citation

Haddad 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. Review. — View Citation

Hrymak 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. Review. — View Citation

Mehta 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. Review. — View Citation

Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414. Review. — View Citation

Raymond M, Grønlykke 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. Review. — View Citation

Richard 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. Review. — View Citation

Rubenfeld 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. — View Citation

Rudski 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. — View Citation

St-Pierre P, Deschamps A, Cartier R, Basmadjian AJ, Denault AY. Inhaled milrinone and epoprostenol in a patient with severe pulmonary hypertension, right ventricular failure, and reduced baseline brain saturation value from a left atrial myxoma. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):723-9. doi: 10.1053/j.jvca.2012.10.017. Epub 2013 Apr 26. — View Citation

Swan 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary	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)	From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours
Secondary	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	Up to 28 days or until hospital discharge
Secondary	Incidence of deaths during hospitalisation	Death from any cause	Up to 28 days or until hospital discharge
Secondary	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.	Up to 28 days or until hospital discharge
Secondary	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	Up to 28 days or until hospital discharge
Secondary	Incidence of surgical reintervention for any reasons	Re-operation after the initial surgery for any cause	Up to 28 days or until hospital discharge
Secondary	Incidence of deep sternal wound infection or mediastinitis	Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician	Up to 28 days or until hospital discharge
Secondary	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).	Up to 28 days or until hospital discharge
Secondary	Incidence of stroke	Central neurologic deficit persisting longer than 72 hours	Up to 28 days or until hospital discharge
Secondary	Total duration of ICU stay in hours	Number of hours passed in the ICU	Up to 28 days or until hospital discharg
Secondary	Duration of vasopressor requirements (in hours)	Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine	Up to 28 days or until hospital discharge
Secondary	Up to 28 days or until hospital discharge	Number of days hospitalized from the day of surgery to discharge	Up to 28 days or until hospital discharge
Secondary	Duration of mechanical ventilation (in hours)	A duration of >24 hours will be considered prolonged ventilation requirements.	Up to 28 days or until hospital discharge
Secondary	Incidence of major morbidity or mortality	Including death, prolonged ventilation, stroke, renal failure (Stage =2), deep sternal wound infection and reoperation for any reason.	Up to 28 days or until hospital discharge
Secondary	Right ventricular ejection fraction	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular fractional area change	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular strain	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Tricuspid annular plane systolic excursion	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular performance index	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Portal flow pulsatility fraction	Portal flow pulsatility fraction	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular stroke work index	0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Relative pulmonary pressure	The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular function index	Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Pulmonary artery pulsatility index (PAPi)	Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Compliance of the pulmonary artery (CPA)	Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Pulsatility of femoral venous flow	Velocity variations of blood flow in the femoral vein during the cardiac cycle	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular outflow tract obstruction	Right Ventricular Systolic pressure minus Pulmonary Artery Systolic pressure = 6 mmHg.	From arrival to the operating room until 2 hours after ICU arrival