NCT00638599

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

March 4, 2008

Last Update Submit

July 14, 2009

Conditions

Breast Cancer

Keywords

Intubation, intratrachealHomeostasisMastectomy, modified radicalBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Circulatory Homeostasis

    15min prior to operation to 15min posterior to operation

Secondary Outcomes (3)

  • Airway pressure

    15min prior to operation to 15min posterior to operation

  • Blood gas

    15min prior to operation to 15min posterior to operation

  • Airway complications

    Start of operation to 6h after operation

Study Arms (2)

1

EXPERIMENTAL

LMA® is placed after anesthesia induction till the end of operation

Device: LMA®

2

ACTIVE COMPARATOR

Standard tracheal tube is inserted after anesthesia induction till the end of operation

Device: Endotracheal tube

Interventions

LMA®DEVICE

LMA® is placed after anesthesia induction and removed after the operation

1
Endotracheal tubeDEVICE

Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

2

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese
  • Diagnosed breast cancer
  • Undergoing modified radical mastectomy
  • Agreed to participate the study with informed contract.

You may not qualify if:

  • Organic dysfunction
  • Long-lasting post-anesthetic care unit(PACU) staying.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 19, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

CN(1)