Inflammatory Response After One-lung Ventilation According to Ventilation Methods

NCT ID: NCT04007354

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2019-05-20

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intubated

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-intubated

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.

Group Type EXPERIMENTAL

Ventilation method

Intervention Type OTHER

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

Interventions

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Ventilation method

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wonjung Hwang

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33831216 (View on PubMed)

Other Identifiers

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KC17EESI0558

Identifier Type: -

Identifier Source: org_study_id

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