- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867814
Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum (SPV-PnP)
Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
Laparoscopic surgery is frequently associated with hemodynamic changes due to pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and occasionally they require active therapeutic interventions or even interruption of the surgical procedure.
One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction of venous return and cardiac preload. Although it has been shown repeatedly that waveform variables are good predictors of cardiac output response to volume loading, the prediction hemodynamic response to decrease of preload is more complex.
The investigators hypothesize that waveform variables will predict cardiac output changes resulting from PnP. Particularly, augmented values of waveform variables before PnP will be associated with a larger decrease of cardiac output after establishing PnP.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Goals of the study
- To evaluate hemodynamic changes caused by pneumoperitoneum applied for laparoscopic surgery
Endpoints
- Blood Pressure: Systolic, Diastolic, Mean (SBP, DBP, MBP)
- Heart Rate (HR)
- Cardiac Output/Index (CO/CI)
- Stroke Volume/Index (SV/SVI)
- Systolic Pressure Variation (SPV)
- Stroke Volume Variation (SVV)
- Plethysmographic Waveform Variation (PWV)
Inclusion criteria
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA (American Society of Anesthesiologists)class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
Exclusion criteria
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
Study course, measurements and analysis
- All study participants will get an explanation and sign on informed consent at least one day prior to the day of surgery
- All study participants will receive standard anesthesia care. All patients will anesthetized intravenously with Fentanyl 2-5 mcg/kg, Propofol 1-2 mg/kg and Rocuronium 0.6-1.0 mg/kg followed by endotracheal intubation. Positive pressure ventilation with tidal volume 8 mL/kg of ideal body weight and respiratory rate 8-12 bpm to achieve end-tidal carbon dioxide of 33-37 mmHg will be applied after intubation. Anesthesia will be maintained with inhalation of Isoflurane (end-expiratory concentration at least 1.2%) in air/O2 (FiO2=0.4). Intraoperative fluid management will include an initial bolus of crystalloid solution (lactated Ringer's solution) at a dose of 7 mL/kg. Arterial blood pressure will be measured continuously through a radial arterial catheter. Pulse oximetry photoplethysmography will be monitored by index finger probe on the same side. Cardiac output will monitored noninvasively by NICOM (Non-invasive cardiac output monitor) that calculates stroke volume variation (SVV) in addition to cardiac output/cardiac index and stroke volume/stroke index
- The study procedure will begin after induction of anesthesia, preparation of the patient for surgery and insertion of the pneumoperitoneum insufflation device. The study procedure will last for 10-15 minutes and will be finished before actual intraperitoneal surgical manipulation begins
- Waveforms will be recorded from the patient monitor and values of NICOM will be noted at baseline before surgical manipulation, at PnP pressure=0 mmHg before gas insufflation but after insertion of peritoneal needle, and after PnP pressure reaches 15 mmHg (routine value for laparoscopic surgery). If after reaching PnP pressure of 15 mmHg CO will decrease by more than 20%, the PnP pressure will be reduced to 10 mmHg and recording of waveforms will be repeated after two minutes
- Standard hemodynamic parameters (heart rate, systolic and diastolic BP) and waveform variables (SPV, PWV) will be measured and calculated offline according to the records
Parameters measured by NICOM (CO, CI, SV, SVI, SVV) will be noted at baseline (PnP pressure=0 mmHg), after PnP pressure reached 15 mmHg and after PnP pressure decreased till 10 mmHg (if necessary)
- There will be no further follow up of the patients
- We anticipate that there will be a significant number of patients with a reduction of CO by 20% or more after establishment of PnP of 15 mm Hg. We will perform comparisons between waveforms at baseline between those who decrease CO and those who do not. If there will be significant difference in variables at baseline there will be justification to perform ROC analysis to evaluate sensitivity and specificity of these variables to predict decrease in CO. In patients who will have a decrease in CO after PnP of 15 mm Hg we will compare the same variables to those that will be reached at PnP of 10 mmHg. These comparisons can help to understand the mechanisms of CO decrease during PnP
- All of the analysis of the data will be performed after removing all identifying data
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reuven Pizov, MD
- Phone Number: 97248250625
- Email: pizov_reuven@clalit.org.il
Study Locations
-
-
-
Haifa, Israel, 34362
- Recruiting
- The Lady Davis Carmel Medical Center
-
Contact:
- Reuven Pizov, MD
- Phone Number: 97248250625
- Email: pizov_reuven@clalit.org.il
-
Principal Investigator:
- Reuven Pizov, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
Exclusion Criteria:
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pneumoperitoneum
Patients undergoing laparoscopic surgery
|
Pneumoperitoneum 15 mmHg and 10 mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output/cardiac index
Time Frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Cardiac output/cardiac index will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
|
Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic pressure variation (SPV)/Pulse pressure variation (PPV)
Time Frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Systolic pressure variation/Pulse pressure variation will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
|
Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plethysmographic Waveform Variation (PWV)
Time Frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Plethysmographic Waveform Variation will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
|
Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pizov Reuven, MD, Carmel Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMC-12-0133-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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