Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Effects of the Degree of Head-down and Pneumoperitoneum During Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02129959
Recruitment Status : Unknown
Verified May 2014 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The aim of this study is to observe the cardiovascular effects of the degree of head-down angle and pneumoperitoneum during laparoscopic procedure using by the fourth version Vigileo-Flotrac system.

Condition or disease
Laparoscopy

Detailed Description:

Laparoscopy for general surgery followed and proved to be advantageous in reduction of postoperative pain, better cosmetic results, quicker return to normal activities, reduction in hospital stay resulting in overall reduction in medical cost, less intraoperative bleeding, less postoperative pulmonary complications, less postoperative wound infection, reduced metabolic derangement, and better postoperative respiratory function. In recent years, advanced laparoscopic surgery has targeted older and sicker patients, rendering anesthesia during laparoscopy more technically demanding. Robotic-assisted laparoscopic radical prostatectomy is rapidly becoming a part of the standard surgical repertoire for the treatment of prostate cancer. Robotic-assisted laparoscopic radical prostatectomy are primarily related to the use of pneumoperitoneum in the steep Trendelenburg position. This combination will affect cerebrovascular, respiratory and hemodynamic homeostasis. The golden standard method for measuring cardiac output in the clinical setting is thermodilution using a pulmonary artery catheter, but the risk of pulmonary artery catheter insertion can not be justified in routine cases. The Vigileo-FloTrac system (Edwards Lifesciences, Irvine, CA, USA), is a less invasive method to obtain continuous CO using pulse contour analysis. The aim of this study is to observe the cardiovascular effects of the degree of head-down angle and pneumoperitoneum during laparoscopic procedure using by the fourth version Vigileo-Flotrac system.

We choose 180 ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study. These surgical procedures include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopic assisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy. These surgical procedures provide the information about the different degree of head-down angle and different intra-abdominal pressure of pneumoperitoneum. Hemodynamic data are recorded immediately after induction of anesthesia; 5 min after induction of pneumoperitoneum; 5, 15, 30, 60 min, and every 30 min if duration more than 60 min after placement in the Trendelenburg position with pneumoperitoneum; and the end.

After observing the cardiovascular effects of degree of head-down, insufflation pressure, duration of surgery, we can prevent the possible complications in advance during laparoscopic surgery. After completing the study, we will be familiar with the use of Vigileo-FloTrac system. We will have more experiences to deal with high-risk patients undergoing simple surgical procedure.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Effects of the Degree of Head-down and Pneumoperitoneum During Laparoscopy
Study Start Date : May 2014
Estimated Primary Completion Date : March 2015

Group/Cohort
laparoscopy
laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopic assisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy



Primary Outcome Measures :
  1. cardiovascular effects [ Time Frame: one year ]
    Hemodynamic data are recorded immediately after induction of anesthesia; 5 min after induction of pneumoperitoneum; 5, 15, 30, 60 min, and every 30 min if duration more than 60 min after placement in the Trendelenburg position with pneumoperitoneum; and the end.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
180 ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study.
Criteria

Inclusion Criteria:

  • ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study.

Exclusion Criteria:

  • preoperative ECG reports and severe obesity (body mass index ≥35 kg/m2)

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): NCT02129959


Contacts
Layout table for location contacts
Contact: Peilin Lin, PhD 886-2-23123456 ext 65518 pll5611@ntu.edu.tw

Locations
Layout table for location information
Taiwan
NTUH Not yet recruiting
Taipei, Taiwan, 100
Contact: Peilin Lin, PhD    886-2-23123456 ext 65518    pll5611@ntu.edu.tw   
Principal Investigator: Peilin Lin, PhD         
Sponsors and Collaborators
National Taiwan University Hospital

Layout table for additonal information
Responsible Party: National Taiwan University Hospital, VS
ClinicalTrials.gov Identifier: NCT02129959     History of Changes
Other Study ID Numbers: 201401041RINC
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: May 2014

Keywords provided by National Taiwan University Hospital:
laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopic
assisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases