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

NCT01867814 | Unknown DMC

• 1 other identifier: CMC-12-0133-CTIL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumoperitoneum; Heart Output Disorder

Outcome Measures

Primary Outcomes (1)

• Cardiac output/cardiac index

  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 Outcomes (1)

• Systolic pressure variation (SPV)/Pulse pressure variation (PPV)

  Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum

Other Outcomes (1)

• Plethysmographic Waveform Variation (PWV)

  Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum

Study Arms (1)

Pneumoperitoneum

EXPERIMENTAL

Patients undergoing laparoscopic surgery

Procedure: Pneumoperitoneum

Interventions

Pneumoperitoneum PROCEDURE

Pneumoperitoneum 15 mmHg and 10 mmHg

Pneumoperitoneum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

The Lady Davis Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Pizov Reuven, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reuven Pizov, MD

CONTACT

97248250625; pizov_reuven@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

IL (1)