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
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Device: Continuous Positive Airway Pressure||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
- 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.
- 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.
- 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
- 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.
- Chest drainage duration [ Time Frame: through study completion, an average of 1 years ]The number of days of the chest drainage will be recorded
- 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
- 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
- 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
- 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
- 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).
- 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
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
|Contact: Adriana Lunardi, PhD||+5511 email@example.com|
|Contact: Elinaldo Santos, PhDfirstname.lastname@example.org|
|Principal Investigator:||Adriana Lunardi, PhD||Universidade Cidade de São Paulo|