NCT06032871

Brief Summary

The goal of this clinical trial is to compare the effectiveness of two airway clearance techniques for patients with ventilator associated pneumonia. The main questions it aim to answer are:

  • effect of the therapies on volume changes
  • outcome on sputum clearance Participants will receive airway clearance techniques of
  • chest physiotherapy
  • high frequency chest wall oscillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

September 5, 2023

Last Update Submit

September 15, 2024

Conditions

Keywords

Airway clearance techniqueVentilator associated pneumoniaElectrical impedance tomographyHigh frequency chest wall oscillationChest physiotherapy

Outcome Measures

Primary Outcomes (1)

  • end-expiratory lung impedance

    Changes of global of impedance of lungs measure by the electrical impedance tomography

    Measurement before intervention, 30 after, 1 hour and 2 hours after intervention

Secondary Outcomes (1)

  • Weight of secretions

    Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention

Study Arms (2)

Chest physiotherapy

EXPERIMENTAL

Patients receive airway clearance by chest physiotherapy for 30 minutes twice a day.

Procedure: Chest physiotherapy

High frequency chest wall oscillation

EXPERIMENTAL

Participants received high frequency chest wall oscillation therapy twice a dy

Procedure: high frequency chest wall oscillation

Interventions

Patients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day.

High frequency chest wall oscillation

Participants received chest physiotherapy twice a day

Chest physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with chronic pulmonary disease
  • Diagnosed with ventilator associated pneumonia
  • Receive airway clearance therapy

You may not qualify if:

  • Head injury, spinal injury
  • Instable hemodynamics
  • Intercranial pressure \> 20 cmH2O
  • Active hemoptysis
  • Empyema
  • Eye surgery
  • Abdominal distension
  • Chest tube insertion
  • Active tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 61363, Taiwan

Location

Related Publications (1)

  • Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Hui-Ling Lin, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The group will be coded and masked to the investigator and the outcome accessor.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

March 16, 2023

Primary Completion

December 12, 2023

Study Completion

December 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations