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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypersecretive Mechanically Ventilated Patients
• Intervention / Treatment: Device: Oscillation and Lung Expansion; Device: High-frequency chest wall oscillation

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jingyi Ge; Email: ge_jingyi2020@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oscillation and Lung Expansion	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.
Experimental: High-frequency chest wall oscillation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Jingyi Ge, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Actual): December 2, 2024
• Study Completion (Estimated): February 13, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical ventilation, Oscillation and Lung Expansion, High-frequency chest wall oscillation, Electrical impedance tomography
• Other Study ID Numbers: 12300126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No