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

Primary Purpose

Esophageal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insufflation of carbon dioxide (CO2)
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Neoplasms focused on measuring Circulatory and Respiratory Physiological Phenomena, Thoracoscopy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Surgery type were converted to thoracotomy,
  • Massive intraoperative blood loss (> 400ml)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Flowrate A

    Flowrate B

    Arm Description

    insufflation of carbon dioxide at 8L/min, 8mmHg

    insufflation of carbon dioxide at 20 L/min, 8mmHg

    Outcomes

    Primary Outcome Measures

    thoracic pressure overshoot
    Time and value of thoracic pressure overshoot during CO2 insufflation
    Hemodynamic change
    Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate
    Respiratory change
    Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide

    Secondary Outcome Measures

    Full Information

    First Posted
    December 24, 2014
    Last Updated
    February 22, 2021
    Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02330536
    Brief Title
    Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery
    Official Title
    Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    July 2020 (Actual)
    Study Completion Date
    July 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Neoplasms
    Keywords
    Circulatory and Respiratory Physiological Phenomena, Thoracoscopy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    232 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Flowrate A
    Arm Type
    Experimental
    Arm Description
    insufflation of carbon dioxide at 8L/min, 8mmHg
    Arm Title
    Flowrate B
    Arm Type
    Experimental
    Arm Description
    insufflation of carbon dioxide at 20 L/min, 8mmHg
    Intervention Type
    Device
    Intervention Name(s)
    Insufflation of carbon dioxide (CO2)
    Intervention Description
    After patients were positioned, CO2 was insufflated into right pleural cavity at eight or twenty L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded.
    Primary Outcome Measure Information:
    Title
    thoracic pressure overshoot
    Description
    Time and value of thoracic pressure overshoot during CO2 insufflation
    Time Frame
    one hour during CO2 insufflation
    Title
    Hemodynamic change
    Description
    Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate
    Time Frame
    one hour during CO2 insufflation
    Title
    Respiratory change
    Description
    Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide
    Time Frame
    one hour during CO2 insufflation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 Surgery type were converted to thoracotomy, Massive intraoperative blood loss (> 400ml)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23549763
    Citation
    Claus CM, Cury Filho AM, Boscardim PC, Andriguetto PC, Loureiro MP, Bonin EA. Thoracoscopic enucleation of esophageal leiomyoma in prone position and single lumen endotracheal intubation. Surg Endosc. 2013 Sep;27(9):3364-9. doi: 10.1007/s00464-013-2918-3. Epub 2013 Apr 3.
    Results Reference
    background
    PubMed Identifier
    14673684
    Citation
    El-Dawlatly AA, Al-Dohayan A, Abdel-Meguid ME, Turkistani A, Alotaiby WM, Abdelaziz EM. Variations in dynamic lung compliance during endoscopic thoracic sympathectomy with CO2 insufflation. Clin Auton Res. 2003 Dec;13 Suppl 1:I94-7. doi: 10.1007/s10286-003-1120-4.
    Results Reference
    background
    PubMed Identifier
    10594427
    Citation
    Brock H, Rieger R, Gabriel C, Polz W, Moosbauer W, Necek S. Haemodynamic changes during thoracoscopic surgery the effects of one-lung ventilation compared with carbon dioxide insufflation. Anaesthesia. 2000 Jan;55(1):10-6. doi: 10.1046/j.1365-2044.2000.01123.x.
    Results Reference
    background
    PubMed Identifier
    35321653
    Citation
    Ren Y, Zhu X, Yan H, Chen L, Mao Q. Cardiorespiratory impact of intrathoracic pressure overshoot during artificial carbon dioxide pneumothorax: a randomized controlled study. BMC Anesthesiol. 2022 Mar 23;22(1):76. doi: 10.1186/s12871-022-01621-9.
    Results Reference
    derived

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