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NCT04007354 Clinical Trial

Inflammatory Response After One-lung Ventilation According to Ventilation Methods

Lung Cancer Clinical Trial

Official title:
Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04007354
Other study ID # KC17EESI0558
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date May 20, 2019

Study information
Verified date June 2019
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 20, 2019
Est. primary completion date April 19, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- elective video-assisted thoracoscopic surgery (VATS) lobectomy

- 20 < age < 75

- American Society of Anesthesiologists (ASA) classification I~II

Exclusion Criteria:

- preoperative inflammation (CRP>10ng/?, WBC>10,000/mm3, body temperature >38?)

- steroid administration within 1 month

- hematologic / autoimmune disease

- congestive heart failure (NYHA class III~IV) or significant arrhythmia

- severe obstructive / restrictive pulmonary disease

- previous history of thoracic surgery

- BMI >28kg/m2

- expected difficult airway

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ventilation method
Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.

Locations
Country Name City State
Korea, Republic of Seoul St.Mary's Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul St. Mary's Hospital The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interleukin (IL)-6 Blood samples collected from the antecubital vein 24 hours after surgery
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