Clinical trial NCT05090696: Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly
Official title: Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Keywords: Airway Obstruction
Mechanical Insufflator Exsufflator
Older Adults
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - older adults, inpatients having airway clearance problem associated with mucus hypersecretion and weak or insufficient cough.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Discomfort
timeFrame: 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).
measure: Relief - change in dyspnea
timeFrame: 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:
measure: Heart rate
timeFrame: 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).
measure: Peak cough flow (PCF)
timeFrame: PCF is measured before and after each session, (8 times totally).
measure: Respiratory rate
timeFrame: Respiratory rate is noted before and after each session, (8 times totally).
measure: Blood pressure
timeFrame: Blood pressure is noted before and after each session, (8 times totally).
measure: Blood oxygen saturation
timeFrame: Blood oxygen saturation is noted before and after each session, (8 times totally).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Claire Estenne
role: PRINCIPAL_INVESTIGATOR
References: