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NCT Number: NCT06675942

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

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.

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Key information

Conditions

Hypersecretive Mechanically Ventilated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Rehabilitation Hospital

Beijing, China

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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 outcomes

  1. Tidal impedance variation (TV)

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

  2. sputum volume

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

  3. Respiratory rate

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

  4. center of ventilation (COV)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyi Ge

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.