Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02886546
• Other study ID #: 2016-06-72(701)
• Status: Not yet recruiting
• Phase: N/A
• First received: August 27, 2016
• Last updated: September 10, 2016
• Start date: September 2016

Study information

• Verified date: September 2016
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: Joohyun Jun, MD
• Phone: +82-10-8864-7731
• Email: ilpleut[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many advantages, including a reduced need for blood transfusion and fewer surgical complications compared with conventional open prostatectomy. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are used to predict and guide fluid therapy during controlled ventilation. These variables arise from heart-lung interactions during positive pressure ventilation, which influence left ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. A recent study established that PPV and SVV derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness during laparoscopic surgery.

The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of fluid responsiveness during laparoscopy with pneumoperitoneum.

The primary objective of this study was to demonstrate that PPV and SVV measured by calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness during RALP, which involves both pneumoperitoneum and the Trendelenburg position. Investigators also assessed the capacity of other dynamic variables (SPV [systolic pressure variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and corrected flow time [FTc]) to predict fluid responsiveness during RALP.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients undergoing elective robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

• patients with a BMI > 30 or , < 15 kg/m2 valvular heart disease left ventricular ejection fraction < 50% a history of lung disease preoperative arrhythmia contraindications to OED monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• pneumoperitoneum

Device:
• oesophageal Doppler monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVV (stroke volume variation)	measured by calibrated pulse contour analysis of CardioQ-ODM+	Measurements were performed before and after volume expansion during pneumoperitoneum	No
Primary	PPV (pulse pressure variation)	measured by calibrated pulse contour analysis of CardioQ-ODM+	Measurements were performed before and after volume expansion during pneumoperitoneum	No
Secondary	SPV (systolic pressure variation)		Measurements were performed before and after volume expansion during pneumoperitoneum	No
Secondary	SVV_flow	determined by ODM Doppler flow	Measurements were performed before and after volume expansion during pneumoperitoneum	No
Secondary	Dynamic elastance	PPV/SVV	Measurements were performed before and after volume expansion during pneumoperitoneum	No
Secondary	FTc (corrected flow time)		Measurements were performed before and after volume expansion during pneumoperitoneum	No