Comparisons of Two Airway Clearance Techniques

September 15, 2024 updated by: Hui-Ling Lin

Comparison of Two Airway Clearance Techniques by Electrical Impedance Tomography- a Parallel Study

The goal of this clinical trial is to compare the effectiveness of two airway clearance techniques for patients with ventilator associated pneumonia. The main questions it aim to answer are:

  • effect of the therapies on volume changes
  • outcome on sputum clearance Participants will receive airway clearance techniques of
  • chest physiotherapy
  • high frequency chest wall oscillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sputum can be accumulated in the airways of intubated patients, resulting in recurrent pneumonia. The airway clearance therapy is often utilized with chest physiotherapy or high frequency chest wall oscillation which has become popular for its easy of use and less time consuming to the healthcare workers. The main questions it aim to answer are on effectiveness of the therapies on lung volume changes and sputum clearance by two airway clearance techniques. With the oscillation of entire chest wall, the investigators hypothesize that the high frequency chest wall oscillation is more effectively clear sputum in the distal airways.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
      • Taoyuan, Taiwan, 61363
        • Chang Gung Memorial 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with chronic pulmonary disease
  • Diagnosed with ventilator associated pneumonia
  • Receive airway clearance therapy

Exclusion Criteria:

  • Head injury, spinal injury
  • Instable hemodynamics
  • Intercranial pressure > 20 cmH2O
  • Active hemoptysis
  • Empyema
  • Eye surgery
  • Abdominal distension
  • Chest tube insertion
  • Active tuberculosis

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chest physiotherapy
Patients receive airway clearance by chest physiotherapy for 30 minutes twice a day.
Procedure: Chest physiotherapy
Participants received chest physiotherapy twice a day
Experimental: High frequency chest wall oscillation
Participants received high frequency chest wall oscillation therapy twice a dy
Procedure: high frequency chest wall oscillation
Patients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
end-expiratory lung impedance
Time Frame: Measurement before intervention, 30 after, 1 hour and 2 hours after intervention
Changes of global of impedance of lungs measure by the electrical impedance tomography
Measurement before intervention, 30 after, 1 hour and 2 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight of secretions
Time Frame: Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention
Sputum amount is weighted.
Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention

Collaborators and Investigators

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

Sponsor

Hui-Ling Lin

Investigators

  • Principal Investigator: Hui-Ling Lin, PhD, Chang Gung University

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 (Actual)

March 16, 2023

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB2212210081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is a plan to make all IPD that underlie results in a publication.

IPD Sharing Time Frame

The protocol is made available starting 6 months after publication.

IPD Sharing Access Criteria

The protocol is access upon request to the principle investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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