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OpenTrials
Completed

NCT Number: NCT04007354

Inflammatory Response After One-lung Ventilation According to Ventilation Methods

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St.Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilation method

Other

Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.

Primary outcomes

  1. Interleukin (IL)-6

    Time frame: 24 hours after surgery

    Blood samples collected from the antecubital vein

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • The Catholic University of Korea

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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