Acute or Chronic Respiratory PathologiesRESPINPADNCT03607032
Use of RespinPAD in Elderly Patients
A study testing Respin Pad and usual treatment in people with Acute or Chronic Respiratory Pathologies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Secretive (or obstructive), acute or chronic pathologies are common in an increasing number of elderly patients. The medical teams are confronted with difficulties in the management of these patients: they do not benefit from optimal respiratory physiotherapy, whether manual or mechanical, due to functional… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute or Chronic Respiratory Pathologies
- What is being tested?
- Respin Pad and usual treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2019to 24 Oct 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient over 70 years of age
- member of the social security system
- hospitalized at the gerontology centre of the CHU de Nice (Cimiez): short geriatric stay, follow-up care and rehabilitation, long-term care unit or EHPAD.
- presenting a clinical bronchial obstruction (auscultatory signs with ronchi type) secondary to a secreting pathology (exacerbation of asthma or chronic obstructive bronchitis, acute bronchitis or acute infectious pneumonitis, repeated swallowing disorders, pulmonary disease of inhalation...) with or without radiological bronchial syndrome.
- for which a respiratory physiotherapy is not effective after expertise of the physiotherapist
Who cannot join
- a patient who is not hemodynamically stable or who has impaired alertness (glasgow<15) or shows signs of respiratory control (choracic-abdominal sway, costal or superclavicular draft, bronchospasm),
- Patient or trustworthy person who did not complete and sign the consent to participate in the study,
- a patient with chest pain, clinical intracranial hypertension (HIC) greater than 20 mmHg, uncontrolled high blood pressure, dyspnea of a different etiology than bronchial obstruction (a rapid and/or poorly tolerated ACFA, clinical or radiological pleural effusion, empyema, pneumothorax, decompensated heart failure, pericarditis, pericarditis
- The patient cannot benefit from naso-tracheal aspiration,
- End-stage palliative care patient
- patient already participating in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of the Use of the RespIn PAD in the Bronchial De-enclosure of Elderly Patients Who Cannot Benefit From Respiratory Physiotherapy
Secretive (or obstructive), acute or chronic pathologies are common in an increasing number of elderly patients. The medical teams are confronted with difficulties in the management of these patients: they do not benefit from optimal respiratory physiotherapy, whether manual or mechanical, due to functional deficiencies, cognitive functions that are sometimes limited or poorly adapted equipment.
The objective of this pilot study is to evaluate the effectiveness of a new RespinPAD device in the bronchial de-encapsulation of elderly patients who cannot benefit from optimal physiotherapy compared to conventional treatment (nasal or bucco-tracheal aspiration and aerosols).
Read more
The study will include 20 non-dementia patients and 20 dementia patients who will benefit from the use of RespinPAD and 20 patients who will benefit from conventional therapy. All the patients included will be over 70 years old and will be recruited when they are admitted to hospital in the geriatric hospital of the CHU de Nice. They will be included if they present a bronchial obstruction secondary to a respiratory pathology secreting whatever the etiology and for which optimal respiratory physiotherapy is not possible after evaluation by a physiotherapist.
Patients using the RespinPAD device will benefit from a 20-minute session twice daily for 5 days.
The primary endpoint (quantitative criterion) will be the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) volumes for each patient included before and after each session of RespinPAD use or conventional treatment for the control group.
Secondary judging criteria will be a heteroassessment of the SEVA (Airway Overcrowding Score), the Borg Scale and the Algoplus or Digital Comfort Scale. For the effectiveness assessment, the SEVA score will allow for a qualitative assessment to complement the primary endpoint. The collection of volumes of secretions, pulse oximeter, mean length of stay, O2 withdrawal time and drug aerosols will also be used to compare results with previous studies. With regard to secondary safety and feasibility criteria, hemodynamic constants, electrocardiogram and the actual duration of the sessions will be recorded.
- Conditions
- Acute or Chronic Respiratory Pathologies
- Being tested
- Respin Pad, usual treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respin PadDevice
RespinPad slid into the back of the patient sitting at 45° in the armchair or bed.
usual treatmentOther
medical aerosol session followed by aspiration or not, as required
| Study group | Role | What they receive |
|---|---|---|
| RespinPad and usual treatment | Experimental | Not described Receives: Device: Respin Pad; Other: usual treatment |
| only usual treatment | Active comparator | Not described Receives: Other: usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2
Measurements of oxygen consumption (VO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.
Measured: 17 months
VCO2
Measurements of carbon dioxide production (VCO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start4 Jan 2019
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute or Chronic Respiratory PathologiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607032
- Sponsor's protocol ID
- 17-PP-17
- Acronym
- RESPINPAD
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Use of the RespIn PAD in the Bronchial De-enclosure of Elderly Patients Who Cannot Benefit From Respiratory Physiotherapy
- ClinicalTrials.gov ID
- NCT03607032
- Acronym / sponsor ID
- RESPINPAD / 17-PP-17
- Conditions
- Acute or Chronic Respiratory Pathologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 31 Jul 2018 (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.
Secretive (or obstructive), acute or chronic pathologies are common in an increasing number of elderly patients. The medical teams are confronted with difficulties in the management of these patients: they do not benefit from optimal respiratory physiotherapy, whether manual or mechanical, due to functional deficiencies, cognitive functions that are sometimes limited or poorly adapted equipment.
The objective of this pilot study is to evaluate the effectiveness of a new RespinPAD device in the bronchial de-encapsulation of elderly patients who cannot benefit from optimal physiotherapy compared to conventional treatment (nasal or bucco-tracheal aspiration and aerosols).
The study will include 20 non-dementia patients and 20 dementia patients who will benefit from the use of RespinPAD and 20 patients who will benefit from conventional therapy. All the patients included will be over 70 years old and will be recruited when they are admitted to hospital in the geriatric hospital of the CHU de Nice. They will be included if they present a bronchial obstruction secondary to a respiratory pathology secreting whatever the etiology and for which optimal respiratory physiotherapy is not possible after evaluation by a physiotherapist.
Patients using the RespinPAD device will benefit from a 20-minute session twice daily for 5 days.
The primary endpoint (quantitative criterion) will be the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) volumes for each patient included before and after each session of RespinPAD use or conventional treatment for the control group.
Secondary judging criteria will be a heteroassessment of the SEVA (Airway Overcrowding Score), the Borg Scale and the Algoplus or Digital Comfort Scale. For the effectiveness assessment, the SEVA score will allow for a qualitative assessment to complement the primary endpoint. The collection of volumes of secretions, pulse oximeter, mean length of stay, O2 withdrawal time and drug aerosols will also be used to compare results with previous studies. With regard to secondary safety and feasibility criteria, hemodynamic constants, electrocardiogram and the actual duration of the sessions will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RespinPad and usual treatment | Experimental | Device: Respin Pad, Other: usual treatment |
| only usual treatment | Active comparator | Other: usual treatment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient over 70 years of age
- member of the social security system
- hospitalized at the gerontology centre of the CHU de Nice (Cimiez): short geriatric stay, follow-up care and rehabilitation, long-term care unit or EHPAD.
- presenting a clinical bronchial obstruction (auscultatory signs with ronchi type) secondary to a secreting pathology (exacerbation of asthma or chronic obstructive bronchitis, acute bronchitis or acute infectious pneumonitis, repeated swallowing disorders, pulmonary disease of inhalation...) with or without radiological bronchial syndrome.
- for which a respiratory physiotherapy is not effective after expertise of the physiotherapist
Key exclusion criteria (6 listed)
- a patient who is not hemodynamically stable or who has impaired alertness (glasgow<15) or shows signs of respiratory control (choracic-abdominal sway, costal or superclavicular draft, bronchospasm),
- Patient or trustworthy person who did not complete and sign the consent to participate in the study,
- a patient with chest pain, clinical intracranial hypertension (HIC) greater than 20 mmHg, uncontrolled high blood pressure, dyspnea of a different etiology than bronchial obstruction (a rapid and/or poorly tolerated ACFA, clinical or radiological pleural effusion, empyema, pneumothorax, decompensated heart failure, pericarditis, pericarditis
- The patient cannot benefit from naso-tracheal aspiration,
- End-stage palliative care patient
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 |
|---|---|---|
| Respin PadRespinPad slid into the back of the patient sitting at 45° in the armchair or bed. | Device | RespinPad and usual treatment |
| usual treatmentmedical aerosol session followed by aspiration or not, as required | Other | RespinPad and usual treatment, only usual treatment |
Primary outcome
VO2
Time frame: 17 months
Measurements of oxygen consumption (VO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.
VCO2
Time frame: 17 months
Measurements of carbon dioxide production (VCO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respin Pad and usual treatment in people with Acute or Chronic Respiratory Pathologies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
VO2 (time frame: 17 months). The study lists 2 primary outcomes in all. 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 18 Nov 2023.