Hemodynamic Effects of Pressure-regulated Volume Control Mode in Patients With Diastolic Dysfunction Undergoing Radical Cystectomy

NCT ID: NCT05048199

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-02-10

Brief Summary

Diastolic function is a combination of ventricular chamber compliance, active myofilament relaxation, and elastic recoil of systolic potential energy. Diastole is classically divided into four stages-isovolumetric relaxation, early rapid filling, late slow filling, and atrial contraction. Isovolumetric relaxation refers to the rapid decrease in LV pressure with little or no change in volume and ends with the opening of the mitral valve and early LV filling. These early phases, sometimes referred to as LV suction, are characterized by a rapid decline in LV intracavity pressure and require energy in the form of ATP to pump cytosolic calcium back into the sarcoplasmic reticulum and enable uncoupling of actin and myosin. Filling later in diastole is more dependent on ventricular compliance.

Up to investigator knowledge, the effect of mechanical ventilation on patient hemodynamics is still unclear especially in patients with diastolic dysfunction. The optimal ventilation mode for anesthesia of patient with diastolic dysfunction remains a subject of debate. The primary outcome of this study is to investigate whether the pressure regulated volume-controlled mode (PRVC) in comparison with the volume-controlled mode in patients with diastolic dysfunction is associated with better hemodynamic alterations and different vasopressors support during anesthesia for radical cystectomy.

Detailed Description

Diastolic dysfunction represents an abnormality in left ventricular relaxation and/or compliance that changes the onset, rate and extent of LV pressure decline and filling during diastole. These changes cause an abnormal relation between LV pressure and volume so that higher filling pressures are required to maintain normal LV end-diastolic volume and cardiac output .Ventricular compliance is affected by numerous factors, including the accumulation of cytoskeletal collagen, which increases with age (over 60 years), longstanding wall stress beyond its physiological reserve, for example, during episodes of uncontrolled systemic hypertension, long term DM, obesity, cardiac ischemia or atrial fibrillation (AF), and various neuro-humoral factors. Less common causes are infiltrative diseases, pericardial constriction, and collection. .

Echocardiographic examination of diastolic function including transmitral flow velocities early (E) and atrial (A), as well as the corresponding velocities of the mitral valve annuli (e' and a'), is currently recommended .After cardiac and noncardiac surgery, diastolic dysfunction is thought to be a risk factor for postoperative consequences including greater mortality and a higher incidence of serious cardiovascular events including myocardial infarction, pulmonary edema, ventricular fibrillation, or primary cardiac arrest and complete heart block. However, the underlying mechanism by which diastolic dysfunction raises the risk of postoperative complications is unknown. Anesthetic drugs may cause altered hemodynamic function and subsequent impairment of diastolic function in patients with diastolic dysfunction, which may be linked to a higher incidence of postoperative problems Positive pressure ventilation is required for anesthesia, and significant volume shifts occur intraoperatively and postoperatively, especially in major surgery. The interactions of positive pressure ventilation with the cardiovascular system are complex and affect both ventricles .Whereas Volume-controlled ventilation ensures the delivery of a defined tidal volume and uses a square waveform flow delivery method that produces high peak airway pressures in low-compliance states. On the other hand, Pressure-regulated volume-controlled (PRVC) mode of ventilation is an example of adaptive targeting mode. There is the adaptive targeting of inspiratory pressure with the aim of delivering the desired minute tidal volume. The ventilator uses a feedback method on breath-to-breath basis to continuously adjust the pressure delivered to achieve the tidal volume target .The effects of different ventilatory modes on patient´s hemodynamics requires further investigations, the increase of the intrathoracic pressure produced by mechanical ventilation can decrease venous return and then preload resulting in decreased cardiac output .

Management of hemodynamics remain one of the core tasks in perioperative and critical care settings. The basis of hemodynamic management in patients undergoing major surgery is formed by a rational titration of fluids, vasopressors and inotropes. the use of dynamic parameters to guide intravenous and inotropic therapy is frequently applied with the intention to optimize peri-operative hemodynamic profiles and maximize oxygen delivery in patients undergoing major abdominal surgery .Direct measurement of SV using noninvasive techniques has become an accepted tool for guiding fluid administration in high risk surgical patients. Dynamic indices have emerged as promising predictors in last decade, and have been proven to predict fluid responsiveness far better than static measures .

This prospective, randomized, cross- over study will be conducted on 76 pairs of patients scheduled for radical cystectomy. A written informed consent will be obtained from all participants in the study.This study will include adult patients -who diagnosed by preoperative cardiac ECHO-with diastolic dysfunction of both sexes. The patients at risk of diastolic dysfunction usually include concomitant comorbidities like long term hypertension, diabetes mellitus, atrial fibrillation or aged patients above 65 years who will scheduled for radical cystectomy and urinary diversion for muscle invasive urinary bladder carcinoma at Mansoura Urology and Nephrology Centre (UNC).

Conditions

Radical Cystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

pressure regulated volume-controlled mode of ventilation (PRVC group)

The mode selected for mechanical ventilation is settled by randomization either PRVC or VCV during radical cystectomy, then the mode of ventilation will be switched to the other mode during urinary diversion till the end of surgery according to the randomization sequence. The tidal volume in both groups will be set to deliver 6-8 mL/kg of ideal body weight. The respiratory rate (RR) will be adjusted to maintain an end tidal CO2 (ETCO2) level of 30-35 mmHg, the inspiratory to expiratory time (I: E) ratio will be1:2 and PEEP 5-8 cmH2O.

Group Type: EXPERIMENTAL

pressure regulated volume-controlled mode of ventilation

Intervention Type: DEVICE

Cardiac output non-invasive monitor for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.

These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4h for 24 hours( P1-P6).

volume-controlled mode of ventilation (VC group)

The mode selected for mechanical ventilation is settled by randomization either PRVC or VCV during radical cystectomy, then the mode of ventilation will be switched to the other mode during urinary diversion till the end of surgery according to the randomization sequence. The tidal volume in both groups will be set to deliver 6-8 mL/kg of ideal body weight. The respiratory rate (RR) will be adjusted to maintain an end tidal CO2 (ETCO2) level of 30-35 mmHg, the inspiratory to expiratory time (I: E) ratio will be1:2 and PEEP 5-8 cmH2O.

Group Type: ACTIVE_COMPARATOR

volume-controlled mode of ventilation

Intervention Type: DEVICE

Cardiac output non-invasive monitor will be used for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.

These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4 hours for 24 hours (P1-P6).

Interventions

pressure regulated volume-controlled mode of ventilation

Cardiac output non-invasive monitor for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.

These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4h for 24 hours( P1-P6).

Intervention Type: DEVICE

volume-controlled mode of ventilation

Cardiac output non-invasive monitor will be used for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.

These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4 hours for 24 hours (P1-P6).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. adult patients with diagnosed diastolic dysfunction.

2. long term controlled hypertension.

3. Long term controlled diabetes mellitus.

4. Controlled atrial fibrillation.

5. Aged patients above 60 years

Exclusion Criteria

1. Patients younger than 18 years.

2. Patients with body mass index (BMI) ˂ 25 and ˃35 wts

3. Major cardiovascular problems with ejection fraction ˂ 40 %.

4. Any implanted mechanical cardiac device

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mahmoud Othman

Professor of anesthesia and surgical Intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud M Othman

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

Locations

Urology and nephrology center

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

MD.21.07.479.R1

Identifier Type: -

Identifier Source: org_study_id