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Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer (LMATBBC)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
LMA®
Endotracheal tube
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Intubation, intratracheal, Homeostasis, Mastectomy, modified radical, Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Chinese
  • Diagnosed breast cancer
  • Undergoing modified radical mastectomy
  • Agreed to participate the study with informed contract.

Exclusion Criteria:

  • Organic dysfunction
  • Long-lasting post-anesthetic care unit(PACU) staying.

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

LMA® is placed after anesthesia induction till the end of operation

Standard tracheal tube is inserted after anesthesia induction till the end of operation

Outcomes

Primary Outcome Measures

Circulatory Homeostasis

Secondary Outcome Measures

Airway pressure
Blood gas
Airway complications

Full Information

First Posted
March 4, 2008
Last Updated
July 14, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00638599
Brief Title
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer
Acronym
LMATBBC
Official Title
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Intubation, intratracheal, Homeostasis, Mastectomy, modified radical, Breast Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
LMA® is placed after anesthesia induction till the end of operation
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard tracheal tube is inserted after anesthesia induction till the end of operation
Intervention Type
Device
Intervention Name(s)
LMA®
Intervention Description
LMA® is placed after anesthesia induction and removed after the operation
Intervention Type
Device
Intervention Name(s)
Endotracheal tube
Intervention Description
Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation
Primary Outcome Measure Information:
Title
Circulatory Homeostasis
Time Frame
15min prior to operation to 15min posterior to operation
Secondary Outcome Measure Information:
Title
Airway pressure
Time Frame
15min prior to operation to 15min posterior to operation
Title
Blood gas
Time Frame
15min prior to operation to 15min posterior to operation
Title
Airway complications
Time Frame
Start of operation to 6h after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese Diagnosed breast cancer Undergoing modified radical mastectomy Agreed to participate the study with informed contract. Exclusion Criteria: Organic dysfunction Long-lasting post-anesthetic care unit(PACU) staying.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

Learn more about this trial

Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer

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