Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-01-05 @ 9:43 PM
Study NCT ID:
NCT03016858
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Study Overview
Official Title:
Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.
Detailed Description:
Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: