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Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

Primary Purpose

Non-small Cell Lung Cancer, Lung Function Decreased, Tracheal Intubation Morbidity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nonintubated thoracoscopic lobectomy
Intubated thoracoscopic lobectomy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Thoracoscopic surgery,Airway Management,Anesthesia

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • adults (> 20 year-old), lung cancer patients undergoing thoracoscopic lobectomy

Exclusion criteria

  • obesity (BMI > 26 kg/m2)
  • previous ipsilateral thoracic surgery
  • severe ventilatory insufficiency (oxygen/BiPAP user)
  • poor cardiopulmonary function (preop forced expiratory volume at one second (FEV1) <60%, preop left ventricular ejection fraction < 50%)
  • autoimmune disease requiring chronic steroids
  • patients with difficult airway management, pregnant women

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nonintubated thoracoscopic lobectomy

Intubated thoracoscopic lobectomy

Arm Description

Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation

Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation

Outcomes

Primary Outcome Measures

Lung function assessment
Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).

Secondary Outcome Measures

Oxidative and systemic inflammatory cytokines.
Oxidative and systemic inflammatory cytokines will be measured from serial blood samples, including 8-isoprostane (pg/mL), malondialdehyde (nM), tumor necrosis factor-alpha (pg/mL), interleukin-6 (pg/mL), interleukin-10 (pg/mL), S100-beta (pg/mL), and neuron specific enolase (ng/mL).

Full Information

First Posted
March 13, 2018
Last Updated
March 19, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03471884
Brief Title
Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection
Official Title
Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A novel nonintubated thoracoscopic technique is promising to enhance recovery after thoracic surgery. However, the effects of nonintubated technique on specific organ protection in not clear yet. In this randomized trial, the effect of nonintubated technique on lung function protection will be evaluated via PaO2/FiO2 ratio, oxidative stress and inflammatory cytokines serially in lung cancer patients undergoing thoracoscopic lobectomy.
Detailed Description
Lung cancer is the leading cause of cancer-related death worldwide. Its incidence is increasingly arising recently. For early-stage non-small cell lung cancer, surgery is the standard treatment that offers best chance of survival. For thoracoscopic lung cancer surgery, tracheal intubation with one-lung ventilation is regarded the standard anesthetic management to establish a safe operating environment. However, complications associated with intubated general anesthesia are not negligible. A novel nonintubated thoracoscopic technique is developing and applied in a variety of thoracic diseases. A previous study showed that nonintubated thoracoscopic lobectomy was feasible and safe in lung cancer patients. Furthermore, nonintubated techniques was also associated with a faster recovery of oral intake, less postoperative complications and shorter hospital stay. The effects of nonintubated thoracoscopic technique on specific organ protection is not clear yet. The aim of this investigation is to explore the effects of nonintubated thoracoscopic lobectomy on lung function protection in lung cancer patients, comparing with the standard intubated patients as a control. The investigators are going to enrol 82 lung cancer patients and randomize them equally to complete thoracoscopic lobectomy with lymphadenectomy either with a nonintubated technique (n=41) or an intubated technique (n=41). The assessment of lung function will be obtained from serial blood gas analyses using PaO2/FiO2 ratio. Additionally, oxidative stress and inflammatory cytokines will be measured from serial blood samples including 8-isoprostane, malondialdehyde, tumor necrosis factor-α, interleukin-6, interleukin-10, S100-β and neuron specific enolase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Lung Function Decreased, Tracheal Intubation Morbidity
Keywords
Thoracoscopic surgery,Airway Management,Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nonintubated thoracoscopic lobectomy
Arm Type
Experimental
Arm Description
Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation
Arm Title
Intubated thoracoscopic lobectomy
Arm Type
Active Comparator
Arm Description
Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation
Intervention Type
Procedure
Intervention Name(s)
Nonintubated thoracoscopic lobectomy
Intervention Description
Nonintubated general anesthesia using fentanyl, target-controlled infusion of propofol to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a spontaneous breathing due to iatrogenic pneumothorax.
Intervention Type
Procedure
Intervention Name(s)
Intubated thoracoscopic lobectomy
Intervention Description
Intubated general anesthesia using 2%-3% sevoflurane and rocuronium to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a endobronchial tube or blocker with use of mechanical ventilation.
Primary Outcome Measure Information:
Title
Lung function assessment
Description
Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Oxidative and systemic inflammatory cytokines.
Description
Oxidative and systemic inflammatory cytokines will be measured from serial blood samples, including 8-isoprostane (pg/mL), malondialdehyde (nM), tumor necrosis factor-alpha (pg/mL), interleukin-6 (pg/mL), interleukin-10 (pg/mL), S100-beta (pg/mL), and neuron specific enolase (ng/mL).
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria adults (> 20 year-old), lung cancer patients undergoing thoracoscopic lobectomy Exclusion criteria obesity (BMI > 26 kg/m2) previous ipsilateral thoracic surgery severe ventilatory insufficiency (oxygen/BiPAP user) poor cardiopulmonary function (preop forced expiratory volume at one second (FEV1) <60%, preop left ventricular ejection fraction < 50%) autoimmune disease requiring chronic steroids patients with difficult airway management, pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Hui Hung, MD, MSc
Phone
02-23123456
Ext
62158
Email
hung.minghui@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shing Chen, MD, PhD
Phone
02-23123456
Ext
65178
Email
chenjs@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Hui Hung, MD, MSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Hui Hung, MD, MSc
Phone
02-23123456
Ext
62158
Email
hung.minghui@gmail.com

12. IPD Sharing Statement

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Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

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