Clinical Trial: Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery

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.


Detailed Summary:

  • 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 con
      Sponsor: Carmel Medical Center

      Current Primary Outcome: 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


      Original Primary Outcome: Same as current

      Current Secondary Outcome: 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


      Original Secondary Outcome: Same as current

      Information By: Carmel Medical Center

      Dates:
      Date Received: May 27, 2013
      Date Started: May 2013
      Date Completion: November 2016
      Last Updated: August 4, 2015
      Last Verified: August 2015