AnaesthesiaPhase 1/2NCT01677442
Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
A Phase 1/2 study testing no-intubated thoracic epidural anesthesia and double-lumen endotracheal intubated anesthesia in people with Anaesthesia and Video Assisted Thoracic Surgery, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anaesthesia, Video Assisted Thoracic Surgery
- What is being tested?
- no-intubated thoracic epidural anesthesia and double-lumen endotracheal intubated anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jul 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510000
Fei Cui, MD.,PhD, 08618902301212, 4641121@qq.com
About this study
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.
Read the 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.
- Conditions
- Anaesthesia, Video Assisted Thoracic Surgery
- Being tested
- no-intubated thoracic epidural anesthesia, double-lumen endotracheal intubated anesthesia
- Keywords
- nonintubated, anaesthesia, VATS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no-intubated thoracic epidural anesthesiaProcedure or surgery
VATS under no-intubated thoracic epidural anesthesia
double-lumen endotracheal intubated anesthesiaProcedure or surgery
VATS under double-lumen endotracheal intubated anesthesia
| Study group | Role | What they receive |
|---|---|---|
| no-intubated group | Experimental | Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace Receives: Procedure: no-intubated thoracic epidural anesthesia |
| intubated group | Active comparator | Active Comparator:double-lumen endotracheal intubated anesthesia Receives: Procedure: double-lumen endotracheal intubated anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery time after intervention of each group
the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
Measured: 7 days
Secondary outcomes (1)
incidence of complications
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Guangzhou Institute of Respiratory Disease
- Investigators
- Jianxing He, Ph.D, M.D., Study chair, Guangzhou Institute of Respiratory DiseaseJun Liu, M.D., Study director, Guangzhou Institute of Respiratory DiseaseFei Cui, Ph.D, M.D., Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677442
- Sponsor's protocol ID
- NTEA001
- Status last verified
- Apr 2012
- First submitted
- 4 May 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01677442
- Acronym / sponsor ID
- NTEA001
- Conditions
- Anaesthesia, Video Assisted Thoracic Surgery
- Keywords
- nonintubated, anaesthesia, VATS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no-intubated group | Experimental | Procedure: no-intubated thoracic epidural anesthesiaExperimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace |
| intubated group | Active comparator | Procedure: double-lumen endotracheal intubated anesthesiaActive Comparator:double-lumen endotracheal intubated anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no-intubated thoracic epidural anesthesiaVATS under no-intubated thoracic epidural anesthesia | Procedure or surgery | no-intubated group |
| double-lumen endotracheal intubated anesthesiaVATS under double-lumen endotracheal intubated anesthesia | Procedure or surgery | intubated group |
Primary outcome
recovery time after intervention of each group
Time frame: 7 days
the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
1 secondary outcome
incidence of complications
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxing He, Ph.D, M.D. study chair
Guangzhou Institute of Respiratory Disease
Jun Liu, M.D. study director
Guangzhou Institute of Respiratory Disease
Fei Cui, Ph.D, M.D. principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing no-intubated thoracic epidural anesthesia and double-lumen endotracheal intubated anesthesia in people with Anaesthesia and Video Assisted Thoracic Surgery, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, MD. (13808880646, cuidavil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery time after intervention of each group (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.