Application and Generalization of Flutter Mucus Clearance Device

NCT ID: NCT00816881

Last Updated: 2012-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

flutter mucus clearance device

Group Type EXPERIMENTAL

flutter mucus clearance device

Intervention Type DEVICE

five minutes every session, four sessions per day

2

Observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flutter mucus clearance device

five minutes every session, four sessions per day

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tongji University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhang Xiangyu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhang Xiangyu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.

Reference Type DERIVED
PMID: 25534580 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHDC12007211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.