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

NCT05048199 | Completed

• 1 other identifier: MD.21.07.479.R1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Radical Cystectomy

Keywords

Diastolic dysfunction; Pressure regulated volume control mode; Cardiac output

Outcome Measures

Primary Outcomes (2)

• 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.

  perioperative time for 24 hours

• 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 .

  perioperative time for 24 hours

Secondary Outcomes (5)

• The incidence of any other inotropic administration during perioperative time

  perioperative time for 24 hours

• The incidence of difficult weaning from mechanical ventilation . -

  End of surgery.

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

  perioperative time for 24 hours.

• The incidence of postoperative hypotension .

  24-hours postoperative

• The incidence postoperative mortality.

  7-days postoperative

Study Arms (2)

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

EXPERIMENTAL

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.

Device: pressure regulated volume-controlled mode of ventilation

volume-controlled mode of ventilation (VC group)

ACTIVE COMPARATOR

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.

Device: volume-controlled mode of ventilation

Interventions

pressure regulated volume-controlled mode of ventilation 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).

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

volume-controlled mode of ventilation 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).

volume-controlled mode of ventilation (VC group)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, 050, Egypt

Location

Study Officials

• Mahmoud M Othman

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and surgical Intensive care

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 17, 2021
• Study Start: November 30, 2021
• Primary Completion: March 1, 2023
• Study Completion: February 10, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)