Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
Started Mar 2018
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 21, 2018
March 1, 2018
10 months
March 13, 2018
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung function assessment
Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).
12 hours
Secondary Outcomes (1)
Oxidative and systemic inflammatory cytokines.
24 hours
Study Arms (2)
Nonintubated thoracoscopic lobectomy
EXPERIMENTALLung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation
Intubated thoracoscopic lobectomy
ACTIVE COMPARATORLung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- adults (\> 20 year-old), lung cancer patients undergoing thoracoscopic lobectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Hui Hung, MD, MSc
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
March 21, 2018
Study Start
March 1, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
March 21, 2018
Record last verified: 2018-03