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

Airway Obstruction Clinical Trial

— INEXPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090696
• Other study ID #: RNI 2021 ESTENNE (INEXPA)
• Secondary ID: 2021-A00891-40
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	Peak cough flow (PCF)	Measurement of PCF through the peak flow meter.	PCF is measured before and after each session, (8 times totally).
Secondary	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).
Secondary	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).
Secondary	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).