Clinical trial NCT06675942: Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients
Official title: Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypersecretive Mechanically Ventilated Patients
Keywords: Mechanical ventilation, Oscillation and Lung Expansion, High-frequency chest wall oscillation, Electrical impedance tomography
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: End-expiratory lung impedance (EELI)
timeFrame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Secondary outcomes:
measure: Tidal impedance variation (TV)
timeFrame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
measure: sputum volume
timeFrame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
measure: Respiratory rate
timeFrame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
measure: center of ventilation (COV)
timeFrame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Rehabilitation Hospital
Study officials:
affiliation: Beijing Rehabilitation Hospital of Capital Medical University
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
References: