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

Breast Cancer Clinical Trial

— LMATBBC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638599
• Other study ID #: NMU-2579-7FW
• Secondary ID: NMU075451
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2008
• Last updated: July 14, 2009
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• LMA®
LMA® is placed after anesthesia induction and removed after the operation
• Endotracheal tube
Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulatory Homeostasis		15min prior to operation to 15min posterior to operation	Yes
Secondary	Airway pressure		15min prior to operation to 15min posterior to operation	Yes
Secondary	Blood gas		15min prior to operation to 15min posterior to operation	Yes
Secondary	Airway complications		Start of operation to 6h after operation	Yes