Respiratory DiseaseNCT01932567
Electrical Impedance Tomography (EIT) and Physiotherapy
A study testing Physiotherapy and Electrical impedance tomography in people with Respiratory Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Physiotherapy and Electrical impedance tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- Aug 2013to Jul 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- Surgery under anesthesia (PEP and incentive spirometry) or healthy subjects
- Intervention time before first bed lift
- Cooperative
- Can perform devices techniques correctly
Who cannot join
- Patients with pacemaker, implantable pumps or automatic implantable cardioverter defibrillator
- Patients with pulmonary disease (acute or chronic)
- Patients with cognitive problems
- Presence of patches or wounds in EIT belt zone placement
- Patients with initial pain > 2/10
- Patients with severe obesity (BMI > 35)
Trial locations and contacts
2 sites in 1 country.
Coralie Colbrant, PT contact
Jean Roeseler contact
Belgium2 sites, 2 recruiting
- Recruiting
Clinique universitaire Saint-Luc
Brussels
Gregory Reychler, PhD
Gregory Reychler, PhD
- Recruiting
Cliniques universitaires Saint-Luc
Brussels
Gregory Reychler, PhD
About this study
Official title: Effect of Physiotherapy Evaluated by Electrical Impedance Tomography
To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography.
- Conditions
- Respiratory Disease
- Being tested
- Physiotherapy, Electrical impedance tomography
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Electrical impedance tomographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Positive expiratory pressure | Experimental | Use of positive expiratory pressure during 3 minutes Receives: Other: Physiotherapy; Procedure: Electrical impedance tomography |
| Incentive spirometry | Experimental | Use of incentive spirometry during 3 minutes Receives: Other: Physiotherapy; Procedure: Electrical impedance tomography |
| manual airway clearance technique | Experimental | Use of manual airway clearance technique during 3 minutes Receives: Other: Physiotherapy; Procedure: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional lung ventilation measured by Electrical impedance tomography
Measured: Recording by electrical impedance tomography will be performed during 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932567
- Sponsor's protocol ID
- physioEIT
- Status last verified
- Jul 2014
- First submitted
- 19 Aug 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy Evaluated by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT01932567
- Acronym / sponsor ID
- physioEIT
- Conditions
- Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- 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.
To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive expiratory pressure | Experimental | Other: Physiotherapy, Procedure: Electrical impedance tomographyUse of positive expiratory pressure during 3 minutes |
| Incentive spirometry | Experimental | Other: Physiotherapy, Procedure: Electrical impedance tomographyUse of incentive spirometry during 3 minutes |
| manual airway clearance technique | Experimental | Other: Physiotherapy, Procedure: Electrical impedance tomographyUse of manual airway clearance technique during 3 minutes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- Surgery under anesthesia (PEP and incentive spirometry) or healthy subjects
- Intervention time before first bed lift
- Cooperative
- Can perform devices techniques correctly
Key exclusion criteria (6 listed)
- Patients with pacemaker, implantable pumps or automatic implantable cardioverter defibrillator
- Patients with pulmonary disease (acute or chronic)
- Patients with cognitive problems
- Presence of patches or wounds in EIT belt zone placement
- Patients with initial pain > 2/10
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 |
|---|---|---|
| Physiotherapy | Other | Incentive spirometry, Positive expiratory pressure, manual airway clearance technique |
| Electrical impedance tomography | Procedure or surgery | Incentive spirometry, Positive expiratory pressure, manual airway clearance technique |
Primary outcome
Regional lung ventilation measured by Electrical impedance tomography
Time frame: Recording by electrical impedance tomography will be performed during 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
Coralie Colbrant, PT contact
Jean Roeseler contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Electrical impedance tomography in people with Respiratory Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2014. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Coralie Colbrant, PT (colbrant.coralie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional lung ventilation measured by Electrical impedance tomography (time frame: Recording by electrical impedance tomography will be performed during 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2014.