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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Diskapi Teaching and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mustafa Ozmen, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01707511
First received: September 15, 2012
Last updated: October 15, 2012
Last verified: October 2012
  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 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mustafa Ozmen, principal İnvestigator, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01707511     History of Changes
Other Study ID Numbers: Diskapianesthesia-01
Study First Received: September 15, 2012
Last Updated: October 15, 2012
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014