Nonintubated Thoracic Epidural Anesthesia Versus Double-l... | NCT01677442

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

May 4, 2012

First Submission Date that Met QC Criteria

Aug 31, 2012

First Posted Date

Sep 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2012

Last Update Posted Date

Sep 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Liu, Director, Guangzhou Institute of Respiratory DiseasePrincipal Investigator

Lead Sponsor

Guangzhou Institute of Respiratory DiseaseOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare results of general Video-assisted Thoracic Surgery (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.

Detailed Description

The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but also a quiet and wide operative field. That's why anaesthesia plays a critical role in thoracoscopic surgery.

General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse effects can derive from this type of anesthesia like intubation-related throat injury, ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid general anesthesia related risks.

Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in such a larger magnitude number and such operation varieties. The investigators hypothesize NTEA could result in less inflammations, lower incidence of complications, less dosage of antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason, the investigators will undertaken a randomized trial comparing results of general VATS operations under NTEA versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.

A total of 500 patients will be included. The study will be performed in the first affiliated hospital of Guangzhou Medical College.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no-intubated group	Experimental	Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace	Procedure: no-intubated thoracic epidural anesthesia
intubated group	Active Comparator	Active Comparator:double-lumen endotracheal intubated anesthesia	Procedure: double-lumen endotracheal intubated anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no-intubated thoracic epidural anesthesia	Procedure	VATS under no-intubated thoracic epidural anesthesia	no-intubated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recovery time after intervention of each group	the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay	7 days

Secondary Outcomes

Measure	Description	Time Frame
incidence of complications		14 days

Other Outcomes

Measure	Description	Time Frame
the inflammation level	hemogram and some inflammatory markers	7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 65 years old
signed inform consent
Tumor size < 6 cm without right or left bronchus invasion
Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L
EF > 50%
PCO2 < 50mmHg,PO2 > 60mmHg（without uptaking oxygen）

Exclusion Criteria:

Psychopath patients who cannot cooperate
ASA score greater than 3
A history of tuberculosis or other signs of intrapleural adhesions
spinal malformation
Hypovolemia or coagulation disorders
BMI > 30
Unfavorable reasons judged by anesthesiologist or surgeon

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Liu, MD.	Contact	13808880646		cuidavil@hotmail.com

Overall Officials

Name	Affiliation	Role
Jianxing He, Ph.D, M.D.	Guangzhou Institute of Respiratory Disease	Study Chair
Jun Liu, M.D.	Guangzhou Institute of Respiratory Disease	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Guangzhou Medical College	Recruiting	Guangzhou	Guangdong	510000	China

References Module

Citations

Not provided