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

NCT06675942 | Recruiting DMC

• 1 other identifier: 12300126
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersecretive Mechanically Ventilated Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

• End-expiratory lung impedance (EELI)

  at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)

Secondary Outcomes (4)

• 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)

Study Arms (2)

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

Interventions

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; Oscillation and Lung Expansion

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.

High-frequency chest wall oscillation; Oscillation and Lung Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Chest Wall Oscillation

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Jingyi Ge

  Beijing Rehabilitation Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyi Ge

CONTACT

ge_jingyi2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 10, 2024
• Primary Completion: December 2, 2024
• Study Completion: February 13, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)