NCT07451405

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

December 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 5, 2026

Status Verified

December 1, 2025

Enrollment Period

17 days

First QC Date

December 30, 2025

Last Update Submit

February 28, 2026

Conditions

Keywords

oscillation and lung expansionhigh frequency chest wallelectrical impedance tomographyAtelectasis

Outcome Measures

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)

    Baseline and 10 days post-treatment

Secondary Outcomes (6)

  • Ventilation distribution on Electrical impedance tomography (EIT) evaluation

    at admission and 3days/7days/10 days after treatment

  • Lung Ultrasound score(LUS)

    at admission and 10 days after treatment

  • Oxygenation index

    at admission and 10 days after treatment

  • the score on Modified Borg dyspnea scale

    at admission and 10 days after treatment

  • The Clinical Pulmonary Infection Score

    from enrollment to 2 weeks after the treatment

  • +1 more secondary outcomes

Study Arms (2)

Coventional therapy group

PLACEBO COMPARATOR

This group conducted casual treatment and airway clearance (except oscillation an lung expansion therapy)

Other: High frequency chest wall oscillation or other airway clearance therapy

OLE group

EXPERIMENTAL

This group conducted casual treatment and oscillation an lung expansion on daily therapy

Other: High frequency chest wall oscillation or other airway clearance therapyOther: Oscillation and lung expansion

Interventions

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...

Coventional therapy groupOLE group

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.

OLE group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemodynamic instability
  • Inhaled oxygen concentration (FiO2) \> 60%
  • Untreated pneumothorax
  • Patients who have undergone total pneumonectomy
  • Hemoptysis
  • Pulmonary bullae, etc.
  • Patients with delirium and restlessness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Respiratory rehabilitation center

Beijing, Beijing Municipality, 100144, China

RECRUITING

Shuo Chen

Beijing, China

COMPLETED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapy

Study Record Dates

First Submitted

December 30, 2025

First Posted

March 5, 2026

Study Start

March 15, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations