Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 1688 for:    CARBON DIOXIDE AND dioxide

Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery

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: NCT02330536
Recruitment Status : Unknown
Verified December 2014 by Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2015
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary:
Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest cavity could increase lung collapse and improve surgical field view. The actual thoracic pressure values may not be identical with the presetting on the insufflator display. This overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung ventilation on the hemodynamic and respiratory function and clarify the relative safety of two different techniques of insufflation.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Device: Insufflation of carbon dioxide (CO2) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery
Study Start Date : December 2014
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flowrate A
insufflation of carbon dioxide at 8L/min
Device: Insufflation of carbon dioxide (CO2)
After patients were positioned, CO2 was insufflated into right pleural cavity at eight or sixteen L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded.

Experimental: Flowrate B
insufflation of carbon dioxide at 16L/min
Device: Insufflation of carbon dioxide (CO2)
After patients were positioned, CO2 was insufflated into right pleural cavity at eight or sixteen L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded.




Primary Outcome Measures :
  1. thoracic pressure overshoot [ Time Frame: one hour during CO2 insufflation ]
    Time and value of thoracic pressure overshoot during CO2 insufflation

  2. Hemodynamic change [ Time Frame: one hour during CO2 insufflation ]
    Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate

  3. Respiratory change [ Time Frame: one hour during CO2 insufflation ]
    Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide



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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical Status Ⅰ,Ⅱ
  • Patients with esophageal carcinoma
  • Elective video-assisted thoracic surgery

Exclusion Criteria:

  • Allergic to drugs used in the study
  • Refusal of VAST
  • Arrhythmia or treated with antiarrhythmic drug

Publications:
Layout table for additonal information
Responsible Party: Qingxiang Mao, M.D., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02330536     History of Changes
Other Study ID Numbers: QMao
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: December 2014
Keywords provided by Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Circulatory and Respiratory Physiological Phenomena
Thoracoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases