An interventional study of Continuous Positive Airway Pressure in Pleural Effusion, sponsored by Universidade Cidade de Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Other
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.
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:
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:
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:
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Universidade Cidade de Sao Paulo is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for professionals:
Inclusion Criteria for patients:
Exclusion Criteria for professionals:
Exclusion Criteria for patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 1 years
Chest drainage duration
The number of days of the chest drainage will be recorded
Time frame: through study completion, an average of 1 years
Hospitalization duration
The days of hospitalization after the chest drainage until the hospital discharge of each patient will be recorded
Time frame: through study completion, an average of 1 years
Rate of pulmonary complications
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
Time frame: through study completion, an average of 1 years
Rate of adverse effects
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
Time frame: through study completion, an average of 1 years
Rate of need for antibiotics therapy
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
Time frame: through study completion, an average of 1 years
Level of tolerance of noninvasive positive pressure use
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).
Time frame: through study completion, an average of 1 years
Pain level of the patient: visual analog scale
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
Time frame: through study completion, an average of 1 years
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Universidade Cidade de Sao Paulo