An observational study in Airway Obstruction, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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.
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.
154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.
This study's enrollment of 15 is below the median of 120 across 59 observational studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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)
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.
Also known as: Cough Assist
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.
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).
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.
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).
Heart rate
Number of contractions of the heart per minute measured with a standard intensive care unit monitoring devices.
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)
Measurement of PCF through the peak flow meter.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Blood oxygen saturation is noted before and after each session, (8 times totally).
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand