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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: Mechanical In-Exsufflator (MI-E)

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 Type: Observational
• Enrollment (Estimated): 29

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Claire Estenne
    • Contact: Lise LACLAUTRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

- older adults, inpatients having airway clearance problem associated with mucus hypersecretion and weak or insufficient cough.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
One group only; 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.; Other Names: Cough Assist

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Claire Estenne, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Older Adults; Airway Obstruction; Mechanical Insufflator Exsufflator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: RNI 2021 ESTENNE (INEXPA); 2021-A00891-40 (Other Identifier: 2021-A00891-40)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No