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Radical CystectomyNCT05048199

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

A study of Radical Cystectomy, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Radical Cystectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteEgypt
Study dates
30 Nov 2021to 10 Feb 2024
Phase
Interventional
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients with diagnosed diastolic dysfunction.
  • long term controlled hypertension.
  • Long term controlled diabetes mellitus.
  • Controlled atrial fibrillation.
  • Aged patients above 60 years

Who cannot join

  • Patients younger than 18 years.
  • Patients with body mass index (BMI) ˂ 25 and ˃35 wts
  • Major cardiovascular problems with ejection fraction ˂ 40 %.
  • Any implanted mechanical cardiac device

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Urology and nephrology center

    Al Mansurah, 050

Other trials in Egypt

About this study

Official title: Hemodynamic Effects of Pressure-regulated Volume Controlled Versus Volume-controlled Ventilation Mode in Patients With Diastolic Dysfunction Undergoing Radical Cystectomy- A Cross Over Randomized Study

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.

Read the 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).

Being tested
pressure regulated volume-controlled mode of ventilation, volume-controlled mode of ventilation
Keywords
Diastolic dysfunction, Pressure regulated volume control mode, Cardiac output

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pressure regulated volume-controlled mode of ventilationDevice

    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 ventilationDevice

    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).

Study groups in NCT05048199
Study groupRoleWhat they receive
pressure regulated volume-controlled mode of ventilation (PRVC group)ExperimentalThe 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.
Receives: Device: pressure regulated volume-controlled mode of ventilation
volume-controlled mode of ventilation (VC group)Active comparatorThe 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.
Receives: Device: volume-controlled mode of ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of noradrenaline use during anesthesia.

    The number of patients that will need noradrenaline as vasopressor during anesthesia with either modes of ventilation to maintain hemodynamic stability.

    Measured: perioperative time for 24 hours

  2. The incidence of Cardiac output changes during anesthesia .

    The number of participants associated with cardiac output and stroke volume drop during anesthesia with each mode of ventilation .

    Measured: perioperative time for 24 hours

Secondary outcomes (5)
  1. The incidence of any other inotropic administration during perioperative time

    The number of participants and total dose of other inotropic administration like dobutamine or dopamine during perioperative time to ensure hemodynamic stability.

    Measured: perioperative time for 24 hours

  2. The incidence of difficult weaning from mechanical ventilation . -

    The number of participants associated with difficult weaning from mechanical ventilation that may be enhanced by diastolic dysfunction in both groups.

    Measured: End of surgery.

  3. Incidence of associated myocardial ischemia, infarction, arrhythmia or cardiogenic pulmonary edema.

    Decrease incidence of associated predefined Myocardial ischemia, infarction, arrhythmia, cardiogenic pulmonary edema.

    Measured: perioperative time for 24 hours.

  4. The incidence of postoperative hypotension .

    The number of participants that will presented with postoperative hypotension with mean arterial blood pressure less than 65 mmHg in both groups

    Measured: 24-hours postoperative

  5. The incidence postoperative mortality.

    The incidence of postoperative mortality of anesthesia related complications.

    Measured: 7-days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start30 Nov 2021
  3. Primary completion1 Mar 2023
  4. Study completion10 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048199
Sponsor's protocol ID
MD.21.07.479.R1
Status last verified
Mar 2024
First submitted
26 Aug 2021
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Radical Cystectomy, run by Mansoura University at 1 site in Egypt.

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 20 Mar 2024. 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 Egypt. 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?

The incidence of noradrenaline use during anesthesia. (time frame: perioperative time for 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Mar 2024.

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