Airway Clearance ImpairmentNCT06032871
Comparisons of Two Airway Clearance Techniques
A study testing high frequency chest wall oscillation and Chest physiotherapy in people with Airway Clearance Impairment, run by Hui-Ling Lin at 2 sites in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Clearance Impairment
- What is being tested?
- high frequency chest wall oscillation and Chest physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 16 Mar 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic pulmonary disease
- Diagnosed with ventilator associated pneumonia
- Receive airway clearance therapy
Who cannot join
- Head injury, spinal injury
- Instable hemodynamics
- Intercranial pressure > 20 cmH2O
- Active hemoptysis
- Empyema
- Eye surgery
Show all 9Show fewer
- Abdominal distension
- Chest tube insertion
- Active tuberculosis
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Chang Gung Memorial Hospital
Taoyuan, 61363
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Clearance Impairment
- Being tested
- high frequency chest wall oscillation, Chest physiotherapy
- Keywords
- Airway clearance technique, Ventilator associated pneumonia, Electrical impedance tomography, High frequency chest wall oscillation, Chest physiotherapy
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency chest wall oscillationProcedure or surgery
Patients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day.
Chest physiotherapyProcedure or surgery
Participants received chest physiotherapy twice a day
| Study group | Role | What they receive |
|---|---|---|
| Chest physiotherapy | Experimental | Patients receive airway clearance by chest physiotherapy for 30 minutes twice a day. Receives: Procedure: Chest physiotherapy |
| High frequency chest wall oscillation | Experimental | Participants received high frequency chest wall oscillation therapy twice a dy Receives: Procedure: high frequency chest wall oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
end-expiratory lung impedance
Changes of global of impedance of lungs measure by the electrical impedance tomography
Measured: Measurement before intervention, 30 after, 1 hour and 2 hours after intervention
Secondary outcomes (1)
Weight of secretions
Sputum amount is weighted.
Measured: Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start16 Mar 2023
- Primary completion12 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Clearance ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Ling Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Hui-Ling Lin, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032871
- Sponsor's protocol ID
- IRB2212210081
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.
PubMed 31113857
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Airway Clearance Techniques by Electrical Impedance Tomography- a Parallel Study
- ClinicalTrials.gov ID
- NCT06032871
- Acronym / sponsor ID
- IRB2212210081
- Conditions
- Airway Clearance Impairment
- Keywords
- Airway clearance technique, Ventilator associated pneumonia, Electrical impedance tomography, High frequency chest wall oscillation, Chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hui-Ling LinUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest physiotherapy | Experimental | Procedure: Chest physiotherapyPatients receive airway clearance by chest physiotherapy for 30 minutes twice a day. |
| High frequency chest wall oscillation | Experimental | Procedure: high frequency chest wall oscillationParticipants received high frequency chest wall oscillation therapy twice a dy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with chronic pulmonary disease
- Diagnosed with ventilator associated pneumonia
- Receive airway clearance therapy
Key exclusion criteria (9 listed)
- Head injury, spinal injury
- Instable hemodynamics
- Intercranial pressure > 20 cmH2O
- Active hemoptysis
- Empyema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency chest wall oscillationPatients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day. | Procedure or surgery | High frequency chest wall oscillation |
| Chest physiotherapyParticipants received chest physiotherapy twice a day | Procedure or surgery | Chest physiotherapy |
Primary outcome
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
1 secondary outcome
Weight of secretions
Time frame: Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 31113857Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Ling Lin, PhD principal investigator
Chang Gung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency chest wall oscillation and Chest physiotherapy in people with Airway Clearance Impairment, run by Hui-Ling Lin at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end-expiratory lung impedance (time frame: Measurement before intervention, 30 after, 1 hour and 2 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06032871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.