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

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00638599
First received: March 4, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Device: LMA®
Device: Endotracheal tube
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Circulatory Homeostasis [ Time Frame: 15min prior to operation to 15min posterior to operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Airway pressure [ Time Frame: 15min prior to operation to 15min posterior to operation ] [ Designated as safety issue: Yes ]
  • Blood gas [ Time Frame: 15min prior to operation to 15min posterior to operation ] [ Designated as safety issue: Yes ]
  • Airway complications [ Time Frame: Start of operation to 6h after operation ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LMA® is placed after anesthesia induction till the end of operation
 Device: LMA®
LMA® is placed after anesthesia induction and removed after the operation
Active Comparator: 2
Standard tracheal tube is inserted after anesthesia induction till the end of operation
 Device: Endotracheal tube
Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638599

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiRong Guo, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00638599     History of Changes
Other Study ID Numbers: NMU-2579-7FW, NMU075451
Study First Received: March 4, 2008
Last Updated: July 14, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Intubation, intratracheal
Homeostasis
Mastectomy, modified radical
Breast Neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013