Application and Generalization of Flutter Mucus Clearance Device

June 21, 2012 updated by: Zhang Xiangyu, Tongji University
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

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
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's 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

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pulmonary department: available to perform the device, in-hospital patients

    • Male and female
    • Age: 45 - 85 years
    • Chronic bronchitis, COPD

  • Thoracic surgery department and surgical department (upper abdomen):

    • Patients with endotracheal intubation of general anesthesia
    • Age: 40-75 years

Exclusion Criteria:

  • Not available to perform the procedure
  • Untreated pneumothorax
  • Diffusion interstitial lung disease
  • Acute coronary syndrome
  • Third stage hypertension
  • Advanced cancer
  • Severe heart, liver, renal , blood system and endocrine system dysfunction
  • Noninvasive mechanical ventilation more than 6 hrs per day
  • Patients with invasive ventilation and cannot weaning and extubation within 48 hours
  • Active hemoptysis

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
flutter mucus clearance device
Device: flutter mucus clearance device
five minutes every session, four sessions per day
NO_INTERVENTION: 2
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Tongji University

Investigators

  • Principal Investigator: Zhang Xiangyu, MD, Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (ESTIMATE)

January 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12007211

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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