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Completed

NCT Number: NCT05090696

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

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.

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Key information

Conditions

Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical In-Exsufflator (MI-E)

Device

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

Primary outcomes

  1. Discomfort

    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).

    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.

  2. Relief - change in dyspnea

    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).

    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.

Secondary outcomes

  1. Heart rate

    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).

    Number of contractions of the heart per minute measured with a standard intensive care unit monitoring devices.

  2. Peak cough flow (PCF)

    Time frame: PCF is measured before and after each session, (8 times totally).

    Measurement of PCF through the peak flow meter.

  3. Respiratory rate

    Time frame: Respiratory rate is noted before and after each session, (8 times totally).

    Number of breaths for one minute measured with a standard intensive care unit monitoring devices.

  4. Blood pressure

    Time frame: Blood pressure is noted before and after each session, (8 times totally).

    Pressure of circulating blood against the walls of blood vessels measured in mmHg with a standard intensive care unit monitoring devices.

  5. Blood oxygen saturation

    Time frame: Blood oxygen saturation is noted before and after each session, (8 times totally).

    Measure of the oxygen level of the blood in percent with a standard intensive care unit monitoring devices.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: INEXPA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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