Clinical Trial: Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia: A pilot randomized controlled trial (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062418) titled 'Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia' on July 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - pneumonia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A study on the feasibility and effectiveness of mechanical insufflation-exsufflation in older patientswith pneumonia. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The intervention program will be initiated within 48 hours of hospitalization. In addition to MI-E, airway clearance techniques (including postural drainage and cough assistance) and an exercise program will be provided. The exercise will be adjusted according to the patient's general condition and physical functional level, starting with bed-based exercises and progressing stepwise to sitting, standing, and walking when feasible. In addition, strengthening exercises mainly targeting the lower limbs and trunk, as well as activities of daily living (ADL) training, will be performed 5-6 days per week. The discontinuation criteria for airway clearance techniques and MI-E will be comprehensively determined when one or more of the following conditions are met: (1) airway suctioning is no longer required; (2) adventitious lung sounds suggestive of airway secretions disappear; and (3) oxygenation status improves. The exercise program including early mobilization will be continued throughout the hospitalization period. Interventions/Control_2 - The control intervention will be initiated within 48 hours of hospital admission. The program will include airway clearance techniques (postural drainage and assisted coughing) and an exercise program incorporating early mobilization. The exercise program will be individualized according to each participant's general medical condition and physical function, beginning with bed-based exercises and progressing, when feasible, to sitting, standing, and ambulation. In addition, lower-extremity and trunk muscle strengthening exercises, as well as activities of daily living (ADL) training, will be provided 5-6 days per week. Airway clearance techniques will be discontinued based on an overall clinical assessment when one or more of the following criteria are met: (1) airway suctioning is no longer required; (2) adventitious lung sounds suggestive of retained airway secretions have resolved; and/or (3) oxygenation has improved. The exercise program, including early mobilization, will be continued throughout the hospitalization.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age sixty-five years or older. Diagnosis of pneumonia and prescription for rehabilitation within forty-eight hours of hospital admission. 2. Inadequate or absent sputum expectoration despite spontaneous coughing. 3. Requirement for tracheal suctioning. Key exclusion criteria - 1. Current or prior pneumothorax, or chronic respiratory disease with pulmonary bullae on chest imaging. 2. Severe heart disease (New York Heart Association [NYHA] functional class III or IV). 3. Comorbidities precluding the application of airway clearance techniques, such as rib fractures or recent thoracotomy. 4. Viral pneumonia. 5. Refusal to provide informed consent for study participation. 6. Requirement for mechanical ventilation. Target Size - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 01 Day Date of IRB - 2026 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071272

Disclaimer: Curated by HT Syndication.