Inflammatory Response After One-lung Ventilation According to Ventilation Methods

NCT04007354 | Completed

• 1 other identifier: KC17EESI0558
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Interleukin (IL)-6

  Blood samples collected from the antecubital vein

  24 hours after surgery

Study Arms (2)

Intubated

NO INTERVENTION

The patient was intubated with a left-sided double-lumen endobronchial tube. The protective ventilation was performed as follows: a tidal volume of 6 mL/kg predicted body weight, I:E ratio of 1:2, a respiratory rate to maintain PaCO2 within 35 to 45 mmHg, and positive end-expiratory pressure at 5 cmH2O. If the airway pressure exceeded 25 cmH2O, tidal volume was adjusted.

Non-intubated

EXPERIMENTAL

The patients were oxygenated via facial mask with O2 5\~10 L/min during the whole procedure. The end-tidal carbon dioxide (EtCO2) was measured by insertion of a detector inside one of the nostrils. Respiration rate was maintained between 12 and 20 breaths/min with adjustment of anesthetics.

Other: Ventilation method

Interventions

Ventilation method OTHER

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

Non-intubated

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective video-assisted thoracoscopic surgery (VATS) lobectomy
• \< age \< 75
• American Society of Anesthesiologists (ASA) classification I\~II

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• The Catholic University of Korea: collaborator

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, South Korea

Location

Related Publications (1)

• Jeon J, Sung S, Moon Y, Koo J, Hyun K, Han K, Hwang W. Comparison of early postoperative cytokine changes in patients undergoing intubated and non-intubated thoracic surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2021 Apr 8;32(3):343-350. doi: 10.1093/icvts/ivaa265.

  PMID: 33831216 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: June 25, 2018
• Primary Completion: April 19, 2019
• Study Completion: May 20, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-06

Locations

KR (1)