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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014