Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness

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: NCT04060069
Recruitment Status : Completed
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tulay Sahin, Kocaeli University

Brief Summary:
The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

Condition or disease Intervention/treatment
Fluid Responsiveness Other: Ringer Lactate

Detailed Description:
After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Before pneumoperitoneum
Fluid administration
Other: Ringer Lactate
Fluids




Primary Outcome Measures :
  1. to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum [ Time Frame: up to 10 months ]
    to evaluate reliability of stroke volume variation in evaluating the response to fluid administration

  2. to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum [ Time Frame: up to 10 months ]
    to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration



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:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.
Criteria

Inclusion Criteria:

  • Age>18 years old patients
  • Will undergo elective laparoscopic gynecological surgery
  • ASA I-II

Exclusion Criteria:

  • Obese patients (body mass index> 30 kg.m2)
  • Patients who had arrhythmia
  • Patients who had cardiac insufficiency.

Layout table for additonal information
Responsible Party: Tulay Sahin, Clinical Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT04060069     History of Changes
Other Study ID Numbers: KOU GOKAEK 2016/272
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases