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

NCT05090696 | Completed

• 2 other identifiers: RNI 2021 ESTENNE (INEXPA)2021-A00891-40
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction

Keywords

Airway Obstruction; Mechanical Insufflator Exsufflator; Older Adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Heart rate

  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)

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

• Respiratory rate

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

• Blood pressure

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

• Blood oxygen saturation

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

Study Arms (1)

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)

Interventions

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.

Also known as: Cough Assist

One group only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Claire Estenne

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 25, 2021
• Study Start: December 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)