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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02330536
Other study ID # QMao
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date July 2020

Study information

Verified date February 2021
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) Physical Status ?,? - 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

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

References & Publications (3)

Brock H, Rieger R, Gabriel C, Pölz 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary thoracic pressure overshoot Time and value of thoracic pressure overshoot during CO2 insufflation one hour during CO2 insufflation
Primary Hemodynamic change Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate one hour during CO2 insufflation
Primary Respiratory change Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide one hour during CO2 insufflation
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