Inflammatory Response After One-lung Ventilation According to Ventilation Methods

July 2, 2019 updated by: Wonjung Hwang, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: Ventilation method
Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin (IL)-6
Time Frame: 24 hours after surgery
Blood samples collected from the antecubital vein
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Actual)

April 19, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KC17EESI0558

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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