The Effect of Oscillation and Lung Expansion (OLE) Therapy in Prolonged Mechanical Ventilated Patients With Atelectasis Evaluated in Multiple Methods

ConditionAtelectasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

High frequency chest wall oscillation (HFCWO) is currently one of the most common and widespread mechanical airway clearance techniques (ACTs) in clinical practice in China. As an external airway oscillation technique, it has been proven in previous clinical practices that it can help clear secretions by vibrating the chest wall, loosening the secretions adhering to the airway walls and promoting ciliary movement, thereby improving lung ventilation and re-expansion. However, there are still some groups of patients for whom this technique is not suitable in clinical practice, such as those who are uncomfortable with the oscillation, have damaged skin on the chest and back, have unstable rib fractures, or have poorly positioned tracheostomy tubes. In recent years, integrating multiple techniques into a single treatment has become a trend. Among them, oscillation and lung expansion (OLE) combines continuous positive airway pressure (CPAP), continuous high-frequency oscillation (CHFO), and nebulization, which can effectively clear airway secretions and promote lung re-expansion. Currently, only a few studies have confirmed that OLE has a positive impact on improving respiratory function in patients with acute respiratory failure, severe burns, and after lung surgery.

This study aims to further compare the effects of the above two mechanical ACTs on improving lung ventilation and re-expansion by electrical impedance tomography (EIT), and optimize the clinical practice of physical therapists.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old

The following characteristics of high mucus secretion in the airway occur along with pulmonary infection: coughing up a large amount of white sticky phlegm, yellow phlegm or yellow purulent phlegm; Phlegm sounds can be heard in the lungs. The frequency of sputum aspiration is higher than once every 4 hours

Tracheotomy time ≥7 days

Vital signs are stable.

Disqualifiers

Hemodynamic instability

Inhaled oxygen concentration (FiO2) > 60%

Untreated pneumothorax

Patients who have undergone total pneumonectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • High frequency chest wall oscillation or other airway clearance therapy

    Other intervention

    High frequency chest wall oscillation (HFCWO) is an external airway oscillation technique, it has been proven in previous clinical practices that it can help clear secretions by vibrating the chest wall, loosening the secretions adhering to the airway walls and promoting ciliary movement, thereby improving lung ventilation and re-expansion. We will give the patients HFCWO twice a day and each time we will give them 15HZ as frequency and 20mins as time. Other therapies are postural drainage, manual vibration...

  • Oscillation and lung expansion

    Other intervention

    oscillation and lung expansion (OLE) combines continuous positive airway pressure (CPAP), continuous high-frequency oscillation (CHFO), and nebulization, which can effectively clear airway secretions and promote lung re-expansion. The OLE will be given to the patients twice a day as well, and each time 10mins therapy with 2.5mins CPAP and 2.5mins CHFO cirsularly.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Coventional therapy groupPlacebo comparator 1 intervention
Group B: OLE groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Atelectatic Lung Area on Chest CT

Atelectatic lung area will be quantified on chest computed tomography (CT) images by a blinded radiologist using imaging analysis software. The primary outcome is the change in atelectatic lung area from baseline to 10 days post-treatment. The unit of the measures is Square centimeters (cm²)

Time frame
Baseline and 10 days post-treatment

Secondary outcomes

1

Ventilation distribution on Electrical impedance tomography (EIT) evaluation

electrical impedance tomography will be used to evaluated the ventilation : Select a large, medium, or small electrode belt according to the patient's body size and place it on the chest (at the level of the 4th-5th intercostal spaces). Ensure that the belt position remains consistent for each measurement. Inject current through the electrode belt and measure the corresponding voltage to reconstruct the intrathoracic impedance distribution and display the corresponding images. Continuously record for 90 seconds and store the EIT data. Global inhomogeneity(GI) value describe the ventilation dstribute, the value is more closer to 0.25, is better.

Time frame
at admission and 3days/7days/10 days after treatment
2

Lung Ultrasound score(LUS)

Lung aeration will be assessed using the Lung Ultrasound Score (LUS).Scan 12 areas to get a relevent score for degrees of lung aeration of each area according the patterns that we got on the lung ultrasound. Each lung region will be scored according to standard criteria, and the total score will be calculated. The outcome measure is the change in total LUS from baseline to 10 days post-treatment. Score ranged from 0 to 36.Higher scores indicate worse lung aeration.

Time frame
at admission and 10 days after treatment
3

Oxygenation index

Oxygenation index is measured by fingertip blood oxygen and is expressed as a percentage.

Time frame
at admission and 10 days after treatment
4

the score on Modified Borg dyspnea scale

a number that reflect the degree of dyspnea on patient reporting according to the Modified Borg dyspnea scale

Time frame
at admission and 10 days after treatment

Other outcomes

Sponsors and contacts

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