Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: Mechanical In-Exsufflator (MI-E)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One group only<br>Participants recruited from patients hospitalized in intensive care units and pulmonary unit of the University Hospital of Clermont-Ferrand, France. | Device: Mechanical In-Exsufflator (MI-E)<br>* 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.<br>* Other names: Cough Assist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Number of contractions of the heart per minute measured with a standard intensive care unit monitoring devices. | 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. | 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. | 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. | 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. | Blood oxygen saturation is noted before and after each session, (8 times totally). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Obstruction, Mechanical Insufflator Exsufflator, Older Adults