Menu
Recruiting NCT06675942

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

No phase Interventional Hypersecretive Mechanically Ventilated Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oscillation and Lung Expansion, High-frequency chest wall oscillation.
Who it may be relevant to
Registry conditions: Hypersecretive Mechanically Ventilated Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device Oscillation and Lung Expansion
    The OLE device (MetaNeb system) is a newer, noninvasive physiotherapy tool that combines mechanical and pharmacological interventions (aerosols) to help mobilize endobronchial secretions.
  • Device High-frequency chest wall oscillation
    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.

Primary outcome measures

  • End-expiratory lung impedance (EELI) [Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
Secondary outcome measures (4)
  • Tidal impedance variation (TV) [Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
  • sputum volume [Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
  • Respiratory rate [Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]
  • center of ventilation (COV) [Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Rehabilitation Hospital — Beijing

Identifiers

NCT: NCT06675942 · 12300126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗