randomised ambulatory management of primary pneumothorax (rampp): protocol of an open-label, randomised controlled trial

by:Sinowon     2019-12-30
【Abstract】 abstract: blood volume is a common clinical problem.
Primary Spontaneous Combustion (PSP)
Occurs in other cases that are suitable for young patients, but there is no clear definition of optimal management, which usually leads to long-term hospital stay.
Although there are outpatient treatment options, the available data on their efficacy are poor.
Randomized outpatient management for primary pneumonia trials is a multi-center randomized controlled trial that compares outpatient management with standard care and is specifically designed to safely and effectively reduce hospital stay.
Methods and analysis will recruit 236 PSP patients from UK hospitals.
Patients will be randomly assigned to the intervention group (
Mobile devices;
Rocket chest cavity)
Or \"control\" arm (
Standard chest leak insertion).
Patients will be followed up for a total of 12 months to assess the recurrence rate.
The main result is the total hospital stay (
Including re-reading)
Up to 30 days after the end.
Secondary outcomes were pain and dyspnea scores, air leakage measurements, and radiation evidence (on CT scanning)of emphysema-
Changes are similar compared to short periods of timeterm and long-
The results of the term and the analysis of the health economy.
Ethics and dissemination the trial was approved by the National Commission for Research Ethics Services
Central Oxford (15/SC/0240).
Registration number isrctn79151659 introduction: blood deficiency is a common clinical problem.
Primary Spontaneous Combustion (PSP)
Occurs in other cases that are suitable for young patients, but there is no clear definition of optimal management, which usually leads to long-term hospital stay.
Although there are outpatient treatment options, the available data on their efficacy are poor.
Randomized outpatient management for primary pneumonia trials is a multi-center randomized controlled trial that compares outpatient management with standard care and is specifically designed to safely and effectively reduce hospital stay.
Methods and analysis will recruit 236 PSP patients from UK hospitals.
Patients will be randomly assigned to the intervention group (
Mobile devices;
Rocket chest cavity)
Or \"control\" arm (
Standard chest leak insertion).
Patients will be followed up for a total of 12 months to assess the recurrence rate.
The main result is the total hospital stay (
Including re-reading)
Up to 30 days after the end.
Secondary outcomes were pain and dyspnea scores, air leakage measurements, and radiation evidence (on CT scanning)of emphysema-
Changes are similar compared to short periods of timeterm and long-
The results of the term and the analysis of the health economy.
Ethics and dissemination the trial was approved by the National Commission for Research Ethics Services
Central Oxford (15/SC/0240).
Registration number isrctn79151659 thorax-
Air in the chest
It is a common pathology.
Primary Spontaneous Combustion (PSP)
Traditionally, it refers to the development of a patient without a potential lung pathology into a chest without trauma.
PSP occurs in about 3000 patients in the UK every year.
1-3 only by close observation can minority groups be managed conservatively.
A recruitment trial is currently being conducted to evaluate the effects of conservative treatment and interventional treatment.
However, many patients will need intervention to re-Lung expansion.
In most patients, consideration is given to the use of a sleeve and syringe to \"breathe\" trapped air, but more than 50% of patients need to be treated by inserting a chest leak and a standard underwater seal.
The average length of stay of patients with inpatient drainage was 6-8 days.
Dynamic management of PSP patients may eliminate the need for long-term inpatient and outpatient treatment.
Reducing the need for chest drainage using bulky underwater systems may make patients more flexible and help with early discharge.
A \"hemlishi Valley \"(one-
The pass valve connected to the chest leak, not the bulky underwater seal)
Has been proposed in any form before-
Access Valve attached to the standard chest drain pipe, as well as a drain pipe and-
Safety valves are integrated into one device.
18 studies were systematically reviewed using dynamic management, reporting an overall success rate of 85.
8% and successful outpatient management 77.
9% of \"rarely Complex.
However, the quality of the evidence is poor and there is a high risk of bias, with only two small randomized trials and the rest being a retrospective case series.
6. Random dynamic management of primary thoracic cavity (RAMPP)
The trial was designed to provide randomized controlled trial data to clearly answer questions about whether dynamic management of PSP patients can safely and effectively reduce hospital stay.
The portable equipment used in this test is the rocket\'s thoracic air vent (
Rocket medical UK)
Designed specifically for the treatment of the chest.
At present, there is no good forecast data to guide management in the short and short term.
Expiration of the period of initial management (
Continuous air leakage or no air leakagere-expanding lung)or long-
There is a chest that appears again in the long term.
Therefore, the RAMPP trial will also collect clinical data, including daily air leakage measurements and computed tomography (CT)
Imaging all patients to potentially produce a predictive tool that allows selective and targeted treatment of patients based on possible outcomes, resulting in more personalized treatment (
And intend to be published separately from the main results of the study).
This study evaluated the random dynamic management of primary thoracic cavity (RAMPP trial)
Is an open multi-center
Comparison of labeling and randomized controlled trials of outpatient management and standard care (
Standard chest leak insertion)
Observational Cohort studies were conducted for patients who did not need intervention.
The trial was sponsored by Oxford University and managed by the Oxford respiratory trial unit (ORTU).
ORTU is responsible for data management.
The trial was registered in the International Registry of standardized randomized controlled trials.
This study was included in the National Institutes of Health Clinical Research Network combination of respiratory and emergency medicine.
The following are the main research questions: For PSP patients, can the use of dynamic devices and treatment strategies significantly reduce hospital stay within the first 30 days of the initial visit?
The following are the second research questions: whether outpatient care and early discharge are safe and cost-effectiveeffective?
Whether the patient experience has been improved through portable devices, including surgical pain, difficulty breathing, quality of life assessment (EuroQol EQ-5D-5L)
What about the time back to work?
What is the recurrence rate of thoracic cavity for more than 6 months and more than 12 months?
Evidence of radiation (on CT scanning)of emphysema-
Like long-term changes and inflammatory predictions. term outcome (
That is, there will be another blood case within 12 months)?
Short-term can be predicted by digitally measuring air leakage and its evolution in the process of treatment
The clinical pathway of long-term treatment of pneumonia, including untreated (
That is, air leakage for a long time or no air leakageexpanded lung)?
Learning Design for two hundred and thirty
Six PSP patients in need of intervention will be recruited from UK centres (
For A list of UK centres, see supplement Appendix A online).
The patient will be randomly assigned an insertion of 1: 1 to the mobile device (
Rocket chest cavity)
Or standard care (
Standard chest leak insertion)
According to the British chest Association (BTS)guidelines.
Seven patients who do not need intervention will be invited to participate in the observational cohort study and the results of that cohort will be published separately.
Supplementary information [bmjresp-2019-000403supp001. pdf]
Patients were involved in the design and conduct of the study.
During the feasibility phase, through discussions with patients in the hospital and during follow-up, the priorities of research issues, outcome measures, and selection of recruitment methods were understoodup in clinic.
The patient representative is an independent member of the trial Steering Committee.
Participants selected all patients who went to the emergency department or the acute medical team to be assessed for eligibility.
Patients may be randomly assigned only once in the RAMPP trial.
However, if patients who were initially registered in the observation queue then need treatment, they can re-enrolled (And re-agree)
The intervention part of the test was randomly grouped.
Standard and free pneumonia confirmed by chest X-ray (CXR)or a CT scan.
Between the ages of 16 and 55.
Ability to agree to participate.
Exclusion criteria for known or suspected potential lung disease (
Including> 20 packs-
History of smoking).
Evidence of Zhang Li\'s bloody chest (
Defined as clinical or ray evidence of a significant increase in intra-thoracic pressure resulting in damage to blood dynamics, requiring emergency decompression).
These patients should be dealt with immediately as a medical emergency.
A woman who is pregnant or breastfeeding.
The trial requirements cannot be agreed or complied.
Taboo certificate for chest surgery (
Only for patients who were included in the intervention or control group, I . e. , the observation group was not included).
The researchers believe that any other major illness or disorder may put participants at risk because of participation in the trial, or may affect the outcome of the trial, or the ability of participants to participate in the trial.
\"Mild\" Asthma is not considered an exclusion criterion.
Patients diagnosed with childhood/youth asthma do not need to use a regular \"preventive\" inhaler (
It contains steroids or long-acting beta-agonist)
Since asthma has never been hospitalized, it is still eligible to participate in the study.
Patients in need of intervention can be enrolled and randomly grouped within 24 hours of the visit, as long as they are still in-patient, and despite the initial intervention, there are ongoing symptomatic Newman (
For example, patients who were initially treated with aspiration overnight)
Chest drainage needs to be inserted now.
Patients who do not need intervention can be included in the observation queue within 2 weeks of initial visits.
Standard and free pneumonia confirmed by chest X-ray (CXR)or a CT scan.
Between the ages of 16 and 55.
Ability to agree to participate.
Exclusion criteria for known or suspected potential lung disease (
Including> 20 packs-
History of smoking).
Evidence of Zhang Li\'s bloody chest (
Defined as clinical or ray evidence of a significant increase in intra-thoracic pressure resulting in damage to blood dynamics, requiring emergency decompression).
These patients should be dealt with immediately as a medical emergency.
A woman who is pregnant or breastfeeding.
The trial requirements cannot be agreed or complied.
Taboo certificate for chest surgery (
Only for patients who were included in the intervention or control group, I . e. , the observation group was not included).
The researchers believe that any other major illness or disorder may put participants at risk because of participation in the trial, or may affect the outcome of the trial, or the ability of participants to participate in the trial.
\"Mild\" Asthma is not considered an exclusion criterion.
Patients diagnosed with childhood/youth asthma do not need to use a regular \"preventive\" inhaler (
It contains steroids or long-acting beta-agonist)
Since asthma has never been hospitalized, it is still eligible to participate in the study.
Patients in need of intervention can be enrolled and randomly grouped within 24 hours of the visit, as long as they are still in-patient, and despite the initial intervention, there are ongoing symptomatic Newman (
For example, patients who were initially treated with aspiration overnight)
Chest drainage needs to be inserted now.
Patients who do not need intervention can be included in the observation queue within 2 weeks of initial visits.
Once a qualified patient has been identified and agreed to participate in the study, the lead researcher or other appropriately qualified authorized person will receive informed written consent.
Since Newman is an acute medical problem, it is not appropriate to wait for the usual 24 hours to give the patient time to read the patient information leaflet before intervention.
Ideally, however, patients should still have a reasonable short period of time to read, digest and ask questions about the study before agreeing.
Centralized web will be used-
Each patient was assigned a random system based on a unique trial number.
Random will continuously reduce the factors that are proposed to solve this problem in order to minimize it (1)
Recruitment Center and (2)
Size of chest (≥4 cm vs
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