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

Not Applicable

Recruiting

• Conditions: Hypersecretive Mechanically Ventilated Patients

• Registration Number: NCT06675942
• Lead Sponsor: Capital Medical University

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).

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Study Start: 2024-11-10
• Primary Completion: 2024-12-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Study Completion: 2025-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Beijing Rehabilitation Hospital; 🇨🇳 Beijing, China