NCT03896672

Clinical Implementation of the Use of Positive Pressure in Chest Drainage

Completed NA Last updated 3 July 2023

What this trial tests

NA trial testing Continuous Positive Airway Pressure in Pleural Effusion in 64 participants. Completed in 31 January 2023.

Timeline

1 September 2019

Primary endpoint
31 January 2021

31 January 2023

Quick facts

Lead sponsor	Universidade Cidade de Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	64
Start date	1 September 2019
Primary completion	31 January 2021
Estimated completion	31 January 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Continuous Positive Airway Pressure

Conditions studied

• Pleural Effusion — all drugs for Pleural Effusion →

Sponsor

Universidade Cidade de Sao Paulo

Who can join

Adults 18 to 85, any sex, with Pleural Effusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Scientific evidence appoints that the use of non-invasive positive airway pressure in pleural effusion drainage patients is associated with a reduction in these complications, as well as with other benefits. Objectives: To test the implementation of the best evidence-based practices for the use of non-invasive continuous positive airway pressure (CPAP) in patients with chest drainage for pleural effusion, by acceptability, reach, appropriateness, direct costs, feasibility, fidelity, penetration, and sustainability. In addition, to assess the impact of implementing these practices on health-related outcomes of patients having their pleural effusion drained through dwelling time of the chest tube, hospital stay and others relevant outcomes. Methods: quasi-experimental study with pretest-posttest design. Eight hospitals that provide physiotherapeutic care to pleural effusion drainage patients will be involved. The study will be developed in three phases. In phase I, a audit team will help the local research team to elaborate strategies to cope with barriers related to the use of CPAP in patients with pleural effusion and catheter drainage, using a interview with the physical therapist, patient history analysis, and interviews with the patients. In implementation phase, the results obtained from phase I will be presented to physiotherapists to physiotherapists and a discussion will be started on the evidence regarding the best practices in the application of CPAP for educational purposes only. In phase III, new interviews will be held with the physical therapist and patients and the patient histories will be analyzed to assess the impact of the intervention 30 days after implementation phase.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use of continuous positive airway pressure in drainage of pleural effusion: Educational intervention for evidence-based practice.
   Santos EDCD, Mendes A, Ohara DG, Silva HVC, et al · · 2024 · PMID 39316892 · DOI 10.1016/j.clinsp.2024.100499