Clinical Implementation of the Use of Positive Pressure in Chest Drainage

NCT ID: NCT03896672

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-01-31

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.

Detailed Description

Design: Effectiveness-implementation hybrid designs, type 3 (primary focus on implementation; secondary focus on effectiveness).

Study setting and Participants: Seven hospitals in Brazil and one in Belgium will be included in the study. The investigators will invite physical therapists working in sectors where patients with pleural effusion and chest tube are hospitalized and the patients themselves to participate in this study.

Study design: The study will be developed in three phases:

• Pre-audit and baseline audit (Phase I)
• Transfer of best practices (Phase II)
• Post-intervention audit (Phase III) a. Pre-audit and baseline audit phase: the purpose of this phase will be to establish the audit team that will discuss the inclusion of health professionals and patients in the study. The audit team will be composed of two local members selected from researchers, clinical director, administrative director, technical director, coordinator, or head of physiotherapy/rehabilitation unit-department in each hospital. As a way to increase physical therapists' participation, the audit team of each hospital will be responsible for the intervention (Phase II - Transfer phase of best practices).

The audit team will check the current local physiotherapeutic practices in the use of Continuous Positive Airway Pressure (CPAP) in patients with pleural effusion drainage exclusively based on scientific evidence and evaluation of the feasibility of measuring the proposed outcomes. In addition, the team will try to identify the possible barriers to be faced in previously scheduled meetings, for example, institutional routines and availability of resources. This audit team can help the research team to develop strategies for coping with these barriers through a structured interview with physical therapists (including questions regarding sociodemographic issues, use of CPAP therapy, physiotherapeutic visits, number of visits and physiotherapeutic techniques) as well as with pleural effusion patients (including questions on the use of therapies applied by the physical therapist, number of daily physiotherapeutic visits, level of tolerance to the use of CPAP, level of satisfaction with physical therapy and level of pain) or by another feasible form discussed at the time. The collection of information from the physiotherapists, patients and medical records simultaneously aims to verify the consistency of the information and the measuring of the outcomes prior to the intervention through historical control.

Audit criteria:

Previously established criteria listed below:

1. Increase in: adherence, adoption, appropriateness, fidelity, tolerability of non-invasive positive pressure treatment, and level of participant satisfaction with treatment.

2. Reduction in: dwelling time of thoracic tube, length of hospital stay, pulmonary complication rate, need for antibiotic therapy, treatment costs, pain level of the patient before and immediately after treatment, and adverse effects.

Baseline evaluation of outcomes and physiotherapeutic practices with CPAP use in patients with pleural effusion and chest tube:

Before the transfer of best practices (Phase II), the outcomes of interest established in the audit criteria will be discussed and confirmed by the audit team, and the clinical practices used by the physical therapist will be identified through interviews, as well as the patients' reports.

In order to assess the efficiency of the implementation process, medical records of patients included in this study will be compared to a historical cohort, i.e. medical records of patients with PE that have been hospitalized in the previous 6 months will be retrieved and compared.

The following information will be collected from the patient medical records:

• Tolerability of CPAP treatment
• Dwelling time of thoracic tube
• Length of hospital stay
• Presence of pulmonary complication
• Use of antibiotics therapy
• Estimate of treatment costs (information that can help in the estimation of costs are, among others: materials and medicines used, hotel, length of stay)
• Presence of adverse effects (aerophagia and pleural or bronchopleural fistula)
• Number of physiotherapy sessions
• Physiotherapy techniques applied to patients

b. Transfer phase of best practices: will also be called the intervention phase. This phase will present to the physical therapists the results extracted from phase I, besides raising a discussion on the best evidence available with mere educational goals. For this intervention, educational materials (seminars, posters, and newsletters), educational outreach activities (interactive face-to-face instruction, workshops, roundtable, and discussion committee), reminders (posters, stickers, and buttons) and messages by electronic media will be used, during an event with the same approaches for each hospital, i.e. continuing education. All approaches will be carried out as homogeneously as possible in all hospital settings to minimize bias.

A full CPAP kit (Müller Resuscitator, Engesp, Brazil) will be donated to each hospital if it is not available onsite. Each kit contains 1 injector, 1 vaporizer, 1 "T" connection, 1 manual valve, 1 oxygen pressure regulator, 2 face masks for inhalation with inflatable cushion, 1 head attachment gear for the mask. In addition, training will be offered on the use of the device.

c. Post-intervention audit phase: all the criteria for inclusion will be maintained in this phase and a new interview will be held with the same physical therapists and patients that have been involved in phase I. Furthermore, medical records of patients and the historical cohort will be analyzed and compared to evaluate the impact of the intervention. This phase will take place 30 days after the end of the second phase, based on a recent study13. In addition, in another study, it was also suggested that this phase can also be started 30 days after the end of the second phase14.

The new structured interview with the physical therapists will occur only once in each phase I and phase III, through a structured form face-to-face or by other communication media, such as email, telephone, or any other means that is convenient for the professional. This will take place in the hospital, office, home or other place and time at the physical therapist's convenience.

The interview with the patients (who have already received or are receiving physical therapy, in order to check what has been done in their physiotherapeutic treatment) will be held by means of a structured form, face-to-face or using other communication media, such as e-mail, telephone, or any other means that is convenient for the patient. The interview will be applied at three different moments. First, within 24 hours after the insertion of chest drain in the hospital. Second, between 10 and 12 days after the drainage tube has been inserted (please correct if I am wrong) and only for the variables infection and pain level. Third, 30 days after the drainage. The two latter interviews will take place in the hospital, office, home or other place and time at the patient's convenience.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment with Continuous Positive Airway Pressure

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

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type: 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.

Interventions

Continuous Positive Airway Pressure

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Graduated physical therapists working in the sectors where patients with PE and chest drainage are hospitalized.

• 18 years or older
• with pleural effusion diagnosed by the physician
• undergo to chest drainage less than 24 hours earlier

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Adriana Claudia Lunardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana Lunardi, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Locations

Hospital das Clínicas Dr. Alberto Lima

Macapá, Amapá, Brazil

Countries

Brazil

References

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

Reference Type: BACKGROUND

PMID: 16272233 (View on PubMed)

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/

Reference Type: BACKGROUND

PMID: 28846252 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20685739 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 24293797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20464170 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25744852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25909064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19925170 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25310789 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26516739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12032977 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10148679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8491630 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21940916 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9769609 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24780633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23578211 (View on PubMed)

Other Identifiers

UNIFAP

Identifier Type: -

Identifier Source: org_study_id