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

February 22, 2021 updated by: Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flowrate A
insufflation of carbon dioxide at 8L/min, 8mmHg
Device: Insufflation of carbon dioxide (CO2)
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.
Experimental: Flowrate B
insufflation of carbon dioxide at 20 L/min, 8mmHg
Device: Insufflation of carbon dioxide (CO2)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thoracic pressure overshoot
Time Frame: one hour during CO2 insufflation
Time and value of thoracic pressure overshoot during CO2 insufflation
one hour during CO2 insufflation
Hemodynamic change
Time Frame: one hour during CO2 insufflation
Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate
one hour during CO2 insufflation
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
one hour during CO2 insufflation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

December 24, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMao

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Neoplasms

Clinical Trials on Insufflation of carbon dioxide (CO2)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe