Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pneumoperitoneum
oesophageal Doppler monitor
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer
Eligibility Criteria
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)
Sites / Locations
Outcomes
Primary Outcome Measures
SVV (stroke volume variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
PPV (pulse pressure variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
Secondary Outcome Measures
SPV (systolic pressure variation)
SVV_flow
determined by ODM Doppler flow
Dynamic elastance
PPV/SVV
FTc (corrected flow time)
Full Information
NCT ID
NCT02886546
First Posted
August 27, 2016
Last Updated
September 10, 2016
Sponsor
Hallym University Kangnam Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02886546
Brief Title
Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
pneumoperitoneum
Intervention Type
Device
Intervention Name(s)
oesophageal Doppler monitor
Other Intervention Name(s)
CardioQ-ODM+
Primary Outcome Measure Information:
Title
SVV (stroke volume variation)
Description
measured by calibrated pulse contour analysis of CardioQ-ODM+
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
Title
PPV (pulse pressure variation)
Description
measured by calibrated pulse contour analysis of CardioQ-ODM+
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
Secondary Outcome Measure Information:
Title
SPV (systolic pressure variation)
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
Title
SVV_flow
Description
determined by ODM Doppler flow
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
Title
Dynamic elastance
Description
PPV/SVV
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
Title
FTc (corrected flow time)
Time Frame
Measurements were performed before and after volume expansion during pneumoperitoneum
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joohyun Jun, MD
Phone
+82-10-8864-7731
Email
ilpleut@hallym.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joohyun Jun, MD
Organizational Affiliation
Hallym University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
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