Clinical Implementation of the Use of Positive Pressure in Chest Drainage

NCT03896672 | Completed DMC

• 1 other identifier: UNIFAP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion

Keywords

Clinical Practice Based on Scientific Evidence; Non-Invasive Positive Airway Pressure; Pleural effusion; Chest drain; Physical therapy

Outcome Measures

Primary Outcomes (6)

• Rate of adherence to treatment by patients and by professionals

  Adherence will be assessed by the level of satisfaction of the treatment with CPAP use among the participants (patients and professionals).

  through study completion, an average of 1 years

• Rate of appropriateness of the treatment according to previous professional training

  Appropriateness will be evaluated through the perception of physical therapist about the adequacy of the use of CPAP for the treatment of patients with PE drained in the hospital environment.

  through study completion, an average of 1 years

• Treatment direct costs

  Treatment costs will be estimated based on the informed daily hospital fees, antibiotics use, physiotherapy session, equipment and accessories for the use of CPAP during the hospitalization period of each patient.

  through study completion, an average of 1 years

• Rate of treatment feasibility

  Feasibility will be evaluated through the success or unsuccess of the use of noninvasive positive pressure in the treatment of drainage drainage within the hospital environment. Successful viability will be determined if there is a decrease in adverse effects, pulmonary complications, and need for antibiotics, and increased tolerance of CPAP use.

  through study completion, an average of 1 years

• Penetration of professional training

  Service access the integration of the use of CPAP in the treatment of chest drained for pleural effusion within the hospital service and its subsystems will be assessed by the following operation: Total number of people with any contact with the service during the year (number of eligible persons who use a service), divided by Total eligible persons at some point during the year (total number of persons eligible for the service)14. This penetration (annual penetration) is the most used in research because it is very easy to perform

  through study completion, an average of 1 years

• Rate of sustainability of professional training

  Sustainability will be assessed by the Level of Institutionalization scales for health promotion programs proposed by Goodman et al.

  through study completion, an average of 1 years

Secondary Outcomes (7)

• Chest drainage duration

  through study completion, an average of 1 years

• Hospitalization duration

  through study completion, an average of 1 years

• Rate of pulmonary complications

  through study completion, an average of 1 years

• Rate of adverse effects

  through study completion, an average of 1 years

• Rate of need for antibiotics therapy

  through study completion, an average of 1 years

Study Arms (1)

Treatment with Continuous Positive Airway Pressure

EXPERIMENTAL

All patients will undergo to physiotherapeutic treatment based on the previous training of the physiotherapist

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

Continuous Positive Airway Pressure will be applied three times daily during 7 consecutive days, if the physiotherapist follow the previous training. Each application should during 30 minutes. Pressure should be adjusted in 15 centimeters of water.

Treatment with Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Graduated physical therapists working in the sectors where patients with PE and chest drainage are hospitalized.
• years or older
• with pleural effusion diagnosed by the physician
• undergo to chest drainage less than 24 hours earlier

You may not qualify if:

• \- Physical therapists taking internships in these hospitals and physical therapists who fail to participate in at least one phase of the study will be excluded.
• \- contraindications for the use of CPAP (such as drowsiness, restlessness, treatment refusal, hemodynamic instability, systolic blood pressure \<90 mmHg, facial trauma, ineffective cough or swallowing impairment, vomiting, upper gastrointestinal bleeding, acute myocardial infarction in the past 48 hours or bullous emphysema).

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas Dr. Alberto Lima

Macapá, Amapá, 68900073, Brazil

Location

Related Publications (17)

• Medford AR, Maskell N. Pleural effusion. Postgrad Med J. 2005 Nov;81(961):702-10. doi: 10.1136/pgmj.2005.035352.

  PMID: 16272233 BACKGROUND

• Krishna R, Antoine MH, Alahmadi MH, Rudrappa M. Pleural Effusion. 2024 Aug 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448189/

  PMID: 28846252 BACKGROUND

• Maskell N; British Thoracic Society Pleural Disease Guideline Group. British Thoracic Society Pleural Disease Guidelines--2010 update. Thorax. 2010 Aug;65(8):667-9. doi: 10.1136/thx.2010.140236. No abstract available.

  PMID: 20685739 BACKGROUND

• McDermott S, Levis DA, Arellano RS. Chest drainage. Semin Intervent Radiol. 2012 Dec;29(4):247-55. doi: 10.1055/s-0032-1330058.

  PMID: 24293797 BACKGROUND

• Oliveira JF, Mello FC, Rodrigues RS, Boechat AL, Conde MB, Menezes SL. Effect of continuous positive airway pressure on fluid absorption among patients with pleural effusion due to tuberculosis. Rev Bras Fisioter. 2010 Mar-Apr;14(2):127-32. doi: 10.1590/s1413-35552010005000001. Epub 2010 Apr 30.

  PMID: 20464170 BACKGROUND

• da Conceicao Dos Santos E, Lunardi AC. Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial. J Physiother. 2015 Apr;61(2):93. doi: 10.1016/j.jphys.2014.11.016. Epub 2015 Mar 3.

  PMID: 25744852 BACKGROUND

• Nedjat S, Gholami J, Yazdizadeh B, Nedjat S, Maleki K, Majdzadeh R. Research's Practice and Barriers of Knowledge Translation in Iran. Iran J Public Health. 2014 Jul;43(7):968-80.

  PMID: 25909064 BACKGROUND

• Karin H, Filip S, Jo G, Bert A. Obstacles to the implementation of evidence-based physiotherapy in practice: a focus group-based study in Belgium (Flanders). Physiother Theory Pract. 2009 Oct;25(7):476-88. doi: 10.3109/09593980802661949.

  PMID: 19925170 BACKGROUND

• Schettino GP, Reis MA, Galas F, Park M, Franca SA, Okamoto VN, Carvalho CR. [Noninvasive mechanical ventilation with positive pressure]. Rev Bras Ter Intensiva. 2007 Jun;19(2):245-57. Portuguese.

  PMID: 25310789 BACKGROUND

• Cortes CT, Santos RC, Caroci Ade S, Oliveira SG, Oliveira SM, Riesco ML. [Implementation methodology of practices based on scientific evidence for assistance in natural delivery: a pilot study]. Rev Esc Enferm USP. 2015 Oct;49(5):716-25. doi: 10.1590/S0080-623420150000500002. Portuguese.

  PMID: 26516739 BACKGROUND

• Stiles PG, Boothroyd RA, Snyder K, Zong X. Service penetration by persons with severe mental illness: how should it be measured? J Behav Health Serv Res. 2002 May;29(2):198-207. doi: 10.1007/BF02287706.

  PMID: 12032977 BACKGROUND

• Steckler A, Goodman RM, McLeroy KR, Davis S, Koch G. Measuring the diffusion of innovative health promotion programs. Am J Health Promot. 1992 Jan-Feb;6(3):214-24. doi: 10.4278/0890-1171-6.3.214.

  PMID: 10148679 BACKGROUND

• Goodman RM, McLeroy KR, Steckler AB, Hoyle RH. Development of level of institutionalization scales for health promotion programs. Health Educ Q. 1993 Summer;20(2):161-78. doi: 10.1177/109019819302000208.

  PMID: 8491630 BACKGROUND

• Scheirer MA, Dearing JW. An agenda for research on the sustainability of public health programs. Am J Public Health. 2011 Nov;101(11):2059-67. doi: 10.2105/AJPH.2011.300193. Epub 2011 Sep 22.

  PMID: 21940916 BACKGROUND

• Barab SA, Redman BK, Froman RD. Measurement characteristics of the levels of institutionalization scales: examining reliability and validity. J Nurs Meas. 1998 Summer;6(1):19-33.

  PMID: 9769609 BACKGROUND

• Scurlock-Evans L, Upton P, Upton D. Evidence-based practice in physiotherapy: a systematic review of barriers, enablers and interventions. Physiotherapy. 2014 Sep;100(3):208-19. doi: 10.1016/j.physio.2014.03.001. Epub 2014 Mar 12.

  PMID: 24780633 BACKGROUND

• Olsen NR, Bradley P, Lomborg K, Nortvedt MW. Evidence based practice in clinical physiotherapy education: a qualitative interpretive description. BMC Med Educ. 2013 Apr 11;13:52. doi: 10.1186/1472-6920-13-52.

  PMID: 23578211 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Adriana Lunardi, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 1, 2019
• Study Start: September 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

BR (1)