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

Sponsored by:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00638599

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 IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anesthesia Breast Cancer Cancer Mastectomy Surgery

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
1: Experimental LMA® is placed after anesthesia induction till the end of operation	Device: LMA® LMA® is placed after anesthesia induction and removed after the operation
2: Active Comparator 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:	Nanjing Medical University ( XiRong Guo )
Study ID Numbers:	NMU-2579-7FW, NMU075451
Study First Received:	March 4, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00638599 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Intubation, intratracheal
Homeostasis
Mastectomy, modified radical
Breast Neoplasms

Study placed in the following topic categories:

Skin Diseases
Anesthetics
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009