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

July 14, 2009 updated by: Nanjing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circulatory Homeostasis
Time Frame: 15min prior to operation to 15min posterior to operation
15min prior to operation to 15min posterior to operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Airway pressure
Time Frame: 15min prior to operation to 15min posterior to operation
15min prior to operation to 15min posterior to operation
Blood gas
Time Frame: 15min prior to operation to 15min posterior to operation
15min prior to operation to 15min posterior to operation
Airway complications
Time Frame: Start of operation to 6h after operation
Start of operation to 6h after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-2579-7FW
  • NMU075451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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