We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Mustafa Ozmen, Diskapi Teaching and Research Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707511
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
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.
Information provided by (Responsible Party):
Mustafa Ozmen, Diskapi Teaching and Research Hospital
  Purpose
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study on Patients Underwent Colorectal Surgery

Further study details as provided by Mustafa Ozmen, Diskapi Teaching and Research Hospital:

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.

Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.

  Eligibility

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled whom planned for elective laparoscopic colorectal resection.
Criteria

Inclusion Criteria:

  • ASA I-III patients underwent laparoscopic colorectal resection

Exclusion Criteria:

  • convertion to the open surgery
  Contacts and Locations
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): NCT01707511


Locations
Turkey
Diskapi Teaching and Research Hospital Recruiting
Ankara, Altindag, Turkey, 06110
Contact: Dilek Yazicioglu, specialist    +903125962553      
Principal Investigator: Mustafa Ozmen, assistant         
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Mustafa Ozmen, MD Diskapi Yildirim Beyazit Training and Research Hospital
  More Information

Responsible Party: Mustafa Ozmen, principal İnvestigator, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01707511     History of Changes
Other Study ID Numbers: Diskapianesthesia-01
First Submitted: September 15, 2012
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Mustafa Ozmen, Diskapi Teaching and Research Hospital:
Arterial carbondioxide pressure
Colon surgery
End-tidal carbondioxide
Laparoscopic Trendelenburg

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases