Airway ObstructionINEXPANCT05090696
Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly
An observational study of Airway Obstruction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Mechanical In-Exsufflator (MI-E)
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 31 Dec 2023
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - older adults, inpatients having airway clearance problem associated with mucus hypersecretion and weak or insufficient cough.
Who may be able to join
- patient hospitalize in Intensive Care Unit or Pulmonary Unit,
- having airway clearance problem associated with mucus hypersecretion,
- peak expiratory flow (PEF) <280 l/min,
- medical indication for respiratory physical therapy.
Who cannot join
- contraindication to use of MI-E device (ex. bronchospasm, immediate follow-up to surgery of airway system, chest or abdominal region, untreated pneumothorax, hemodynamic failure, etc.),
- refuse to participate,
- pregnant,
- breastfeeding,
- insufficient cognitive status.
Trial locations and contacts
1 site in 1 country.
About this study
The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.
Read the detailed description
Background: One of the most frequent reasons for hospital admission of older adults are respiratory disorders. Physiological aging processes decrease respiratory muscle strength and can reduce the efficacity of cough. The mechanical in-exsufflator (MI-E) is a medical device used to help coughing. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular pathologies however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.
Methods: Feasibility will be evaluated by outcomes such as the discomfort of each session (use of a numerical scale of discomfort from 0 to 10) and the relief felt before and after each session (use of a modified Borg scale to quantify dyspnea). Two sessions a day of MI-E will be done for a total of four sessions. Furthermore, other outcomes shall be used, before and after each session, such as vital signs (heart and respiratory rate, blood pressure and oxygen saturation), auscultation as well as the measure of cough peak flow.
Discussion: The protocol of this study is the first to evaluate the use of MI-E in hospitalized older adults by the measure of discomfort and relief. In regard to literature on the use of MI-E in patients suffering from neuromuscular pathologies and on the effects of aging on the respiratory system, the hypothesis of the study seems justified. On top of bringing physical benefits to the patient, the study will pave the way for other randomized controlled studies.
- Conditions
- Airway Obstruction
- Being tested
- Mechanical In-Exsufflator (MI-E)
- Keywords
- Airway Obstruction, Mechanical Insufflator Exsufflator, Older Adults
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical In-Exsufflator (MI-E)Device
Also called Cough Assist
The feasibility will be estimated by quantifying relief and discomfort of four MI-E sessions (2 days x 2 sessions = 4 sessions). Vital signs will be also noted before and after such MI-E session.
| Study group | Role | What they receive |
|---|---|---|
| One group only | Participants recruited from patients hospitalized in intensive care units and pulmonary unit of the University Hospital of Clermont-Ferrand, France. Receives: Device: Mechanical In-Exsufflator (MI-E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort
Use of a numerical scale of discomfort from 0 to 10, (0 - very comfortable, 10 - extremely uncomfortable). The percentage of sessions being evaluated less than or equal to 6 will be presented.
Measured: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Discomfort is evaluated after each MI-E session, (4 evaluations totally).
Relief - change in dyspnea
Use of a modified Borg scale to quantify dyspnea, (0 - no dyspnea, 10 - maximal dyspnea). Relief is defined as a change in Borg score of dyspnea before and after each MI-E session.
Measured: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Relief is evaluated for each session, (4 evaluations totally/8 Borg scores).
Secondary outcomes (5)
Heart rate
Number of contractions of the heart per minute measured with a standard intensive care unit monitoring devices.
Measured: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Heart rate is noted before and after each session, (8 times totally).
Peak cough flow (PCF)
Measurement of PCF through the peak flow meter.
Measured: PCF is measured before and after each session, (8 times totally).
Respiratory rate
Number of breaths for one minute measured with a standard intensive care unit monitoring devices.
Measured: Respiratory rate is noted before and after each session, (8 times totally).
Blood pressure
Pressure of circulating blood against the walls of blood vessels measured in mmHg with a standard intensive care unit monitoring devices.
Measured: Blood pressure is noted before and after each session, (8 times totally).
Blood oxygen saturation
Measure of the oxygen level of the blood in percent with a standard intensive care unit monitoring devices.
Measured: Blood oxygen saturation is noted before and after each session, (8 times totally).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start15 Dec 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Estenne, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090696
- Sponsor's protocol ID
- RNI 2021 ESTENNE (INEXPA)
- Other IDs
- 2021-A00891-40
- Acronym
- INEXPA
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly
- ClinicalTrials.gov ID
- NCT05090696
- Acronym / sponsor ID
- INEXPA / RNI 2021 ESTENNE (INEXPA)
- Conditions
- Airway Obstruction
- Keywords
- Airway Obstruction, Mechanical Insufflator Exsufflator, Older Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Oct 2021 (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 mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.
Detailed description
Background: One of the most frequent reasons for hospital admission of older adults are respiratory disorders. Physiological aging processes decrease respiratory muscle strength and can reduce the efficacity of cough. The mechanical in-exsufflator (MI-E) is a medical device used to help coughing. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular pathologies however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.
Methods: Feasibility will be evaluated by outcomes such as the discomfort of each session (use of a numerical scale of discomfort from 0 to 10) and the relief felt before and after each session (use of a modified Borg scale to quantify dyspnea). Two sessions a day of MI-E will be done for a total of four sessions. Furthermore, other outcomes shall be used, before and after each session, such as vital signs (heart and respiratory rate, blood pressure and oxygen saturation), auscultation as well as the measure of cough peak flow.
Discussion: The protocol of this study is the first to evaluate the use of MI-E in hospitalized older adults by the measure of discomfort and relief. In regard to literature on the use of MI-E in patients suffering from neuromuscular pathologies and on the effects of aging on the respiratory system, the hypothesis of the study seems justified. On top of bringing physical benefits to the patient, the study will pave the way for other randomized controlled studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group only | – | Device: Mechanical In-Exsufflator (MI-E)Participants recruited from patients hospitalized in intensive care units and pulmonary unit of the University Hospital of Clermont-Ferrand, France. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - older adults, inpatients having airway clearance problem associated with mucus hypersecretion and weak or insufficient cough.
Key inclusion criteria (4 listed)
- patient hospitalize in Intensive Care Unit or Pulmonary Unit,
- having airway clearance problem associated with mucus hypersecretion,
- peak expiratory flow (PEF) <280 l/min,
- medical indication for respiratory physical therapy.
Key exclusion criteria (5 listed)
- contraindication to use of MI-E device (ex. bronchospasm, immediate follow-up to surgery of airway system, chest or abdominal region, untreated pneumothorax, hemodynamic failure, etc.),
- refuse to participate,
- pregnant,
- breastfeeding,
- insufficient cognitive status.
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 |
|---|---|---|
| Mechanical In-Exsufflator (MI-E)Also: Cough AssistThe feasibility will be estimated by quantifying relief and discomfort of four MI-E sessions (2 days x 2 sessions = 4 sessions). Vital signs will be also noted before and after such MI-E session. | Device | One group only |
Primary outcome
Discomfort
Time frame: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Discomfort is evaluated after each MI-E session, (4 evaluations totally).
Use of a numerical scale of discomfort from 0 to 10, (0 - very comfortable, 10 - extremely uncomfortable). The percentage of sessions being evaluated less than or equal to 6 will be presented.
Relief - change in dyspnea
Time frame: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Relief is evaluated for each session, (4 evaluations totally/8 Borg scores).
Use of a modified Borg scale to quantify dyspnea, (0 - no dyspnea, 10 - maximal dyspnea). Relief is defined as a change in Borg score of dyspnea before and after each MI-E session.
5 secondary outcomes
Heart rate
Time frame: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Heart rate is noted before and after each session, (8 times totally).
Peak cough flow (PCF)
Time frame: PCF is measured before and after each session, (8 times totally).
Respiratory rate
Time frame: Respiratory rate is noted before and after each session, (8 times totally).
Blood pressure
Time frame: Blood pressure is noted before and after each session, (8 times totally).
Blood oxygen saturation
Time frame: Blood oxygen saturation is noted before and after each session, (8 times totally).
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.
Related trials for Airway Obstruction
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
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.
Claire Estenne principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 5 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 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?
Discomfort (time frame: The MI-E sessions are realized once in the morning and once in the afternoon on two consecutive days, (4 MI-E sessions totally). Discomfort is evaluated after each MI-E session, (4 evaluations totally).). 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 19 Sep 2024.