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Clinical Implementation of the Use of Positive Pressure in Chest Drainage

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ClinicalTrials.gov Identifier: NCT03896672
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Continuous Positive Airway Pressure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: How To Use Non-Invasive Positive Airway Pressure In Pleural Effusion Drainage: Protocol For Implementation Multicentric Scientific Evidence With Audit
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : April 2020

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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.


Secondary Outcome Measures :
  1. Chest drainage duration [ Time Frame: through study completion, an average of 1 years ]
    The number of days of the chest drainage will be recorded

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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).

  7. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896672


Contacts
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Contact: Adriana Lunardi, PhD +5511 21781310 adriana.lunardi@unicid.edu.br
Contact: Elinaldo Santos, PhD drelinaldo@yahoo.com.br

Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Adriana Lunardi, PhD Universidade Cidade de São Paulo

Publications:

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Responsible Party: Adriana Claudia Lunardi, Principal Investigator, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03896672     History of Changes
Other Study ID Numbers: UNIFAP
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo:
Clinical Practice Based on Scientific Evidence
Non-Invasive Positive Airway Pressure
Pleural effusion
Chest drain
Physical therapy
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases