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Use of RespinPAD in Elderly Patients (RESPINPAD)

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ClinicalTrials.gov Identifier: NCT03607032
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:

Secretive (or obstructive), acute or chronic pathologies are common in an increasing number of elderly patients. The medical teams are confronted with difficulties in the management of these patients: they do not benefit from optimal respiratory physiotherapy, whether manual or mechanical, due to functional deficiencies, cognitive functions that are sometimes limited or poorly adapted equipment.

The objective of this pilot study is to evaluate the effectiveness of a new RespinPAD device in the bronchial de-encapsulation of elderly patients who cannot benefit from optimal physiotherapy compared to conventional treatment (nasal or bucco-tracheal aspiration and aerosols).

The study will include 20 non-dementia patients and 20 dementia patients who will benefit from the use of RespinPAD and 20 patients who will benefit from conventional therapy. All the patients included will be over 70 years old and will be recruited when they are admitted to hospital in the geriatric hospital of the CHU de Nice. They will be included if they present a bronchial obstruction secondary to a respiratory pathology secreting whatever the etiology and for which optimal respiratory physiotherapy is not possible after evaluation by a physiotherapist.

Patients using the RespinPAD device will benefit from a 20-minute session twice daily for 5 days.

The primary endpoint (quantitative criterion) will be the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) volumes for each patient included before and after each session of RespinPAD use or conventional treatment for the control group.

Secondary judging criteria will be a heteroassessment of the SEVA (Airway Overcrowding Score), the Borg Scale and the Algoplus or Digital Comfort Scale. For the effectiveness assessment, the SEVA score will allow for a qualitative assessment to complement the primary endpoint. The collection of volumes of secretions, pulse oximeter, mean length of stay, O2 withdrawal time and drug aerosols will also be used to compare results with previous studies. With regard to secondary safety and feasibility criteria, hemodynamic constants, electrocardiogram and the actual duration of the sessions will be recorded.


Condition or disease Intervention/treatment Phase
Acute or Chronic Respiratory Pathologies Device: Respin Pad Other: usual treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of the Use of the RespIn PAD in the Bronchial De-enclosure of Elderly Patients Who Cannot Benefit From Respiratory Physiotherapy
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : May 15, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: RespinPad and usual treatment Device: Respin Pad
RespinPad slid into the back of the patient sitting at 45° in the armchair or bed.

Other: usual treatment
medical aerosol session followed by aspiration or not, as required
Active Comparator: only usual treatment Other: usual treatment
medical aerosol session followed by aspiration or not, as required


Outcome Measures
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Primary Outcome Measures :
  1. VO2 [ Time Frame: 17 months ]
    Measurements of oxygen consumption (VO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.

  2. VCO2 [ Time Frame: 17 months ]
    Measurements of carbon dioxide production (VCO2) (quantitative) volumes on each patient included before and after each RespinPad session, and before and after each conventional treatment for the control group.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 70 years of age
  • member of the social security system
  • hospitalized at the gerontology centre of the CHU de Nice (Cimiez): short geriatric stay, follow-up care and rehabilitation, long-term care unit or EHPAD.
  • presenting a clinical bronchial obstruction (auscultatory signs with ronchi type) secondary to a secreting pathology (exacerbation of asthma or chronic obstructive bronchitis, acute bronchitis or acute infectious pneumonitis, repeated swallowing disorders, pulmonary disease of inhalation...) with or without radiological bronchial syndrome.
  • for which a respiratory physiotherapy is not effective after expertise of the physiotherapist

Exclusion Criteria:

  • a patient who is not hemodynamically stable or who has impaired alertness (glasgow<15) or shows signs of respiratory control (choracic-abdominal sway, costal or superclavicular draft, bronchospasm),
  • Patient or trustworthy person who did not complete and sign the consent to participate in the study,
  • a patient with chest pain, clinical intracranial hypertension (HIC) greater than 20 mmHg, uncontrolled high blood pressure, dyspnea of a different etiology than bronchial obstruction (a rapid and/or poorly tolerated ACFA, clinical or radiological pleural effusion, empyema, pneumothorax, decompensated heart failure, pericarditis, pericarditis
  • The patient cannot benefit from naso-tracheal aspiration,
  • End-stage palliative care patient
  • patient already participating in another study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607032


Locations
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France
Nice Hospital Recruiting
Nice, France, 06000
Contact: Cyprien ARLAUD    33492034052    arlaud.c@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03607032    
Other Study ID Numbers: 17-PP-17
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No