Breast CancerPhase 4LMATBBCNCT00638599
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer
A Phase 4 study testing LMA® and Endotracheal tube in people with Breast Cancer, run by Nanjing Medical University at 1 site in China.
Trial summary
Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LMA® and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jul 2009
- Phase
- Phase 4
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese
- Diagnosed breast cancer
- Undergoing modified radical mastectomy
- Agreed to participate the study with informed contract.
Who cannot join
- Organic dysfunction
- Long-lasting post-anesthetic care unit(PACU) staying.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer
Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.
- Conditions
- Breast Cancer
- Being tested
- LMA®, Endotracheal tube
- Keywords
- Intubation, intratracheal, Homeostasis, Mastectomy, modified radical, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA®Device
LMA® is placed after anesthesia induction and removed after the operation
Endotracheal tubeDevice
Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LMA® is placed after anesthesia induction till the end of operation Receives: Device: LMA® |
| 2 | Active comparator | Standard tracheal tube is inserted after anesthesia induction till the end of operation Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulatory Homeostasis
Measured: 15min prior to operation to 15min posterior to operation
Secondary outcomes (3)
Airway pressure
Measured: 15min prior to operation to 15min posterior to operation
Blood gas
Measured: 15min prior to operation to 15min posterior to operation
Airway complications
Measured: Start of operation to 6h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638599
- Sponsor's protocol ID
- NMU-2579-7FW
- Other IDs
- NMU075451
- Acronym
- LMATBBC
- Status last verified
- Jul 2009
- First submitted
- 4 Mar 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer
- ClinicalTrials.gov ID
- NCT00638599
- Acronym / sponsor ID
- LMATBBC / NMU-2579-7FW
- Conditions
- Breast Cancer
- Keywords
- Intubation, intratracheal, Homeostasis, Mastectomy, modified radical, Breast Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Mar 2008 (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.
Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: LMA®LMA® is placed after anesthesia induction till the end of operation |
| 2 | Active comparator | Device: Endotracheal tubeStandard tracheal tube is inserted after anesthesia induction till the end of operation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese
- Diagnosed breast cancer
- Undergoing modified radical mastectomy
- Agreed to participate the study with informed contract.
Key exclusion criteria (2 listed)
- Organic dysfunction
- Long-lasting post-anesthetic care unit(PACU) staying.
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 |
|---|---|---|
| LMA®LMA® is placed after anesthesia induction and removed after the operation | Device | 1 |
| Endotracheal tubeStandard endotracheal tube is inserted after anesthesia induction and extubated after the operation | Device | 2 |
Primary outcome
Circulatory Homeostasis
Time frame: 15min prior to operation to 15min posterior to operation
3 secondary outcomes
Airway pressure
Time frame: 15min prior to operation to 15min posterior to operation
Blood gas
Time frame: 15min prior to operation to 15min posterior to operation
Airway complications
Time frame: Start of operation to 6h after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LMA® and Endotracheal tube in people with Breast Cancer, run by Nanjing Medical University 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jul 2009. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulatory Homeostasis (time frame: 15min prior to operation to 15min posterior to operation). 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 15 Jul 2009.