Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients

NCT06675942 — Not applicable, Recruiting, 24 participants, Capital Medical University

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Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients: a Randomized Crossover Trial

Registry	NCT06675942
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	24 (Estimated)
Sponsor	Capital Medical University (Other)
Conditions	Hypersecretive Mechanically Ventilated Patients
Interventions	Oscillation and Lung Expansion, High-frequency chest wall oscillation (Device)
Dates	start 2024-11-10, primary completion 2024-12-02, completion 2025-02-13 (estimated), first posted 2024-11-06, last updated 2025-01-22
Locations	1 site in China

-Summary

Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. This increases the risk of pneumonia and lung atelectasis. Usual care for mechanically ventilated patients includes airway suctioning via the tracheostomy tube, which clears only a limited portion of the airway and is ineffective at removing peripheral airway secretions.

To address this, airway clearance guidelines recommend various airway clearance techniques (ACTs) for mechanically ventilated patients to enhance mucus removal. However, the lack of standardized, effective evaluation criteria makes selecting the optimal ACT a challenge.

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+Detailed description

The aim of this randomized cross-over study was to compare the effectiveness of oscillation and lung expansion (OLE) versus high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by EIT, in medically complex, hypersecretive patients with tracheostomy tubes requiring long-term mechanical ventilation (MV).

+Arms and interventions

Arm	Type	Interventions	Description
Oscillation and Lung Expansion	Experimental	Device: Oscillation and Lung Expansion; Device: High-frequency chest wall oscillation
High-frequency chest wall oscillation	Experimental	Device: Oscillation and Lung Expansion; Device: High-frequency chest wall oscillation

Oscillation and Lung Expansion (Device): The OLE device (MetaNeb system) is a newer, noninvasive physiotherapy tool that combines mechanical and pharmacological interventions (aerosols) to help mobilize endobronchial secretions.
High-frequency chest wall oscillation (Device): High-frequency chest wall oscillation (HFCWO) is an airway clearance technique that uses external forces applied to the chest via an inflatable vest connected to a device that generates vibrations at varying frequencies and pressures.

+Outcome measures

Primary outcomes

End-expiratory lung impedance (EELI) [at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]

Secondary outcomes

Tidal impedance variation (TV) [at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
sputum volume [at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
Respiratory rate [at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
center of ventilation (COV) [at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Eligible participants were patients aged ≥18 years with airway hypersecretion, admitted to the ICU,
* Requiring more than 48 hours of MV.

Exclusion Criteria:

* Malignant arrhythmia
* Acute myocardial ischemia
* Pneumothorax, pulmonary bulla, barotrauma, or other lung diseases,
* Hemorrhagic disease or coagulation abnormalities with bleeding tendencies
* Skin trauma on the chest
* Pulmonary embolism
* Presence of a permanent or temporary pacemaker
* Untreated spinal and rib fractures
* Any condition deemed inappropriate for study inclusion by the researchers.

+Locations (1)

Facility	City	Country	Status
Beijing Rehabilitation Hospital	Beijing	China	Recruiting

+Investigators

Jingyi Ge, Principal investigator, Beijing Rehabilitation Hospital of Capital Medical University