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Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum (SPV-PnP)

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ClinicalTrials.gov Identifier: NCT01867814
Recruitment Status : Unknown
Verified August 2015 by Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : June 4, 2013
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pneumoperitoneum Heart Output Disorder Procedure: Pneumoperitoneum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
Study Start Date : May 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Pneumoperitoneum
Patients undergoing laparoscopic surgery
Procedure: Pneumoperitoneum
Pneumoperitoneum 15 mmHg and 10 mmHg




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867814


Contacts
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Contact: Reuven Pizov, MD 97248250625 pizov_reuven@clalit.org.il

Locations
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Israel
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Reuven Pizov, MD    97248250625    pizov_reuven@clalit.org.il   
Principal Investigator: Reuven Pizov, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Pizov Reuven, MD Carmel Medical Center
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Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01867814    
Other Study ID Numbers: CMC-12-0133-CTIL
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases