Clinical Implementation of the Use of Positive Pressure in Chest Drainage

June 28, 2023 updated by: Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo

How To Use Non-Invasive Positive Airway Pressure In Pleural Effusion Drainage: Protocol For Implementation Multicentric Scientific Evidence With Audit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Amapá
      • Macapá, Amapá, Brazil, 68900073
        • Hospital das Clínicas Dr. Alberto Lima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for professionals:

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

Inclusion Criteria for patients:

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

Exclusion Criteria for professionals:

- 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.

Exclusion Criteria for patients:

- 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Continuous Positive Airway Pressure
All patients will undergo to physiotherapeutic treatment based on the previous training of the physiotherapist
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adherence to treatment by patients and by professionals
Time Frame: through study completion, an average of 1 years
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
Time Frame: through study completion, an average of 1 years
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
Time Frame: through study completion, an average of 1 years
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
Time Frame: through study completion, an average of 1 years
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
Time Frame: through study completion, an average of 1 years
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
Time Frame: through study completion, an average of 1 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest drainage duration
Time Frame: through study completion, an average of 1 years
The number of days of the chest drainage will be recorded
through study completion, an average of 1 years
Hospitalization duration
Time Frame: through study completion, an average of 1 years
The days of hospitalization after the chest drainage until the hospital discharge of each patient will be recorded
through study completion, an average of 1 years
Rate of pulmonary complications
Time Frame: through study completion, an average of 1 years
the complications considered will be: pneumonia, atelectasis, or lung entrapment. These complications will be recorded based on clinical, laboratory and imaging exams up to the hospital discharge
through study completion, an average of 1 years
Rate of adverse effects
Time Frame: through study completion, an average of 1 years
the adverse effects for the use of noninvasive positive pressure considered will be aerophagia and bronchopleural fistula. These adverse effects will be recorded until the hospital discharge
through study completion, an average of 1 years
Rate of need for antibiotics therapy
Time Frame: through study completion, an average of 1 years
Need for antibiotics therapy: it will be registered based on the medical prescription on the 1st day of hospitalization, between 3 and 4 days, between 10 and 12 days, and 30 days after the chest drainage
through study completion, an average of 1 years
Level of tolerance of noninvasive positive pressure use
Time Frame: through study completion, an average of 1 years
tolerance will be assessed using the visual analog scale from zero to ten, zero corresponding to fully tolerable (no discomfort) and ten to totally intolerable (unbearable discomfort).
through study completion, an average of 1 years
Pain level of the patient: visual analog scale
Time Frame: through study completion, an average of 1 years
the pain level of the patient will be assessed using the visual analogic scale ranging from zero to ten, where zero equals the total absence of pain and ten equals unbearable pain, during the patient's inclusion, between 10 and 12 days, and 30 days after the chest drainage
through study completion, an average of 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Cidade de Sao Paulo

Investigators

  • Principal Investigator: Adriana Lunardi, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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