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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06675942
Enrollment
24
Registered
2024-11-06
Start date
2024-11-10
Completion date
2025-02-13
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersecretive Mechanically Ventilated Patients

Keywords

Mechanical ventilation, Oscillation and Lung Expansion, High-frequency chest wall oscillation, Electrical impedance tomography

Brief 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.

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).

Interventions

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 (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.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Tidal impedance variation (TV)at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
sputum volumeat the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Respiratory rateat 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)

Countries

China

Contacts

Primary ContactJingyi Ge
ge_jingyi2020@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026