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Inflammatory Response After One-lung Ventilation According to Ventilation Methods

S

Seoul St. Mary's Hospital

Status

Completed

Conditions

Lung Cancer

Treatments

Other: Ventilation method

Study type

Interventional

Funder types

Other

Identifiers

NCT04007354
KC17EESI0558

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Intubated
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Other: Ventilation method

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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