Analysis of the Profile of Patients Diagnosed With Bronchiectasis Referred to the Respiratory Physiotherapy Unit of the Rehabilitation Service in the A Coruña and Cee Health Area: a Retrospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Anthropometric characteristics
研究概览
简要总结
Study design: observational, retrospective Population: 270 patients diagnosed with bronchiectasis (BX) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area.
Objective:
To determine the profile of patients diagnosed with BX (not due to cystic fibrosis) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area between 1 January 2022 and 1 March 2026.
Hypotheses:
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Main hypothesis These patients exhibit a high degree of heterogeneity. It is expected that the characterisation of these patients' clinical and functional variables-such as lung function, respiratory muscle strength, frequency of exacerbations and chronic bronchial colonisation by microorganisms-will enable the identification of distinct patterns within this population.
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Secondary hypotheses
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Patients with a higher burden of comorbidity have a poorer clinical prognosis and make greater use of resources.
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Respiratory rehabilitation interventions will lead to improvements in these variables.
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The combined analysis of clinical, functional and microbiological variables will enable the identification of patient profiles at higher risk.
Applicability: The study will provide specific and up-to-date knowledge, enabling the optimisation of follow-up strategies and the adaptation of RF interventions to patients' actual needs, thereby improving the quality of care. The results will contribute to the formulation of new research questions.
Ethical considerations: The information will be processed in a pseudonymised manner, ensuring the confidentiality and security of the data in accordance with the General Data Protection Regulation. Given the retrospective nature of the study and compliance with the established pseudonymisation requirements, an exemption from informed consent will be requested from the Ethics Committee, in accordance with Additional Provision 17 of Organic Law 3/2018, relating to the processing of health data for research purposes, justified by the minimal risk involved and the privacy controls in place for the information.
Estimated duration: 9-10 months from the date of approval by the Ethics Committee, including data collection, statistical analysis and the dissemination of results.
Budget: No external funding required. Conclusion: This project will provide detailed and rigorous clinical information on patients with bronchiectasis in real-world clinical practice.
详细描述
The applicability of the study is based on the following aspects:
- Generation of real-world data The retrospective analysis will provide information derived from routine clinical practice, complementing the evidence from clinical trials and providing data representative of the healthcare context within the Galician health system.
- Potential improvement in clinical practice The identification of clinical profiles, associated comorbidities and variables related to disease progression may help to optimise clinical follow-up models, facilitate risk stratification and promote more personalised care for patients with BX.
- Organisational impact and healthcare efficiency Understanding the characteristics and care needs of this cohort will help to guide future organisational strategies, improve resource planning and facilitate interventions aimed at reducing exacerbations, hospitalisations and avoidable healthcare utilisation.
- Basis for future lines of research The results obtained may generate hypotheses for subsequent prospective studies and multicentre projects, contributing to the development of clinical research into chronic respiratory conditions within the public healthcare system.
- Ethical proportionality and risk minimisation As this is a single-centre, retrospective, observational study based exclusively on the review of existing clinical data, with no intervention in patients' care or modification of their clinical management, the risk to participants is minimal. The data will be processed in a pseudonymised form, ensuring confidentiality in accordance with Regulation (EU) 2016/679 and current Spanish legislation on personal data protection and biomedical research.
Overall, the project has high clinical and organisational applicability, as it generates knowledge that is directly transferable to clinical practice, with an appropriate risk-benefit balance and clear social value aimed at improving healthcare for patients with BX.
METHODOLOGY Scope of the study The study population will consist of 270 patients diagnosed with BX who are being treated at the Respiratory Rehabilitation Unit of the Rehabilitation Service in the A Coruña and Cee area, referred from the Pulmonology Department at HUAC. Data will be collected retrospectively through a review of medical records.
Study period The period over which data will be collected will run from 1 January 2022 to 1 March 2026.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with BX via imaging studies such as high-resolution computed tomography, in accordance with validated clinical and radiological criteria.
- •Patients treated at the Respiratory Rehabilitation Unit of the Rehabilitation Service in the A Coruña and Cee area between 1 January 2022 and 1 March 2026, having completed the physiotherapy intervention programme.
- •Adult patients, aged ≥18 years at the time of diagnosis.
- •Minimum information available in the electronic health record, including: demographic data (age, sex); data on bronchial colonisation; data on lung function (spirometry); records of exacerbations and/or hospital admissions; and data on respiratory treatments received.
排除标准
- •Patients with an uncertain or unconfirmed diagnosis of BX.
- •Patients with a diagnosis of cystic fibrosis.
- •Incomplete medical records that prevent the collection of variables essential to the study.
结局指标
主要结局
Anthropometric characteristics
时间窗: Baseline
Age (years)
Lifestyle habits
时间窗: Baseline
* Smoking status: yes/no * Former smoker: yes/no (defined as having given up smoking for ≥ 4 months).
Characteristics of the pathological process: aetiology.
时间窗: Baseline
Post-infectious, inflammatory, immunological, congenital or other
Radiological findings:
时间窗: Baseline
Confirmation of the diagnosis using high-resolution computed tomography, type of bronchiectasis and radiological extent.
Clinical findings. Modified Medical Research Council Dyspnoea Scale
时间窗: Periprocedural.
The Modified Medical Research Council (mMRC) Dyspnoea Scale is a tool for assessing the patient's sensation of breathlessness and is used to classify the severity of dyspnoea into five levels, ranging from zero - which indicates the absence of dyspnoea - to four, which represents severe dyspnoea that limits everyday activities.
Microbiological Analysis of Sputum
时间窗: Periprocedural
Types of bacteria and fungi found in sputum.
Laboratory test.
时间窗: Values recorded in the most recent laboratory test in the medical record at the time the respiratory physical therapy program begins.
C-reactive protein (CRP), measured in mg/L
Bronchiectasis severity scale: E-FACED
时间窗: Periprocedural
It is a multidimensional tool that enables the stratification of the risk of exacerbations, hospitalisations and mortality. It is valued exacerbations, spirometric data, age, pseudomonas colonisation, computed tomography extent and dyspnoea.Each variable is scored on a dichotomous scale, with a total range of increasing severity from 0 to 9 points, where 0-3 points indicate mild bronchiectasis, 4-6 points moderate bronchiectasis and 7-9 points severe bronchiectasis.
Pharmacological treatment.
时间窗: Periprocedural
Corticosteroids, antibiotics, inhaled bronchodilators and saline solution.
Comorbidities.
时间窗: Baseline
Bronchial colonisation and other pulmonary complications (sleep apnoea syndrome (OSA)), cardiovascular, neurological, gastrointestinal (hiatal hernia), rheumatic, oncological or osteoarticular conditions.
Exacerbations of bronchiectasis
时间窗: The year prior to the start of respiratory physiotherapy treatment
Number of hospital admissions prior to respiratory physiotherapy treatment
Exacerbations of bronchiectasis
时间窗: From the end of treatment up to 1 year later.
Number of readmissions following respiratory physiotherapy treatment
Physiotherapy on the ward during hospitalisation
时间窗: Periprocedural.
Yes /no
Characteristics of physiotherapy treatment. Type of treatment (by duration):
时间窗: Periprocedural.
Physiotherapy treatment 1 (8 weeks, rehabilitation protocol comprising education, bronchial clearance, strength training and aerobic exercise): duration (8 weeks, yes/no), interruptions to the programme and the reason for each interruption. Physiotherapy treatment 2 (10 sessions comprising education, bronchial clearance and exercise): interruptions and reason for each interruption. Physiotherapy treatment 3 (1 session comprising education and bronchial clearance).
Treatment techniques used in the pulmonary rehabilitation programme (yes/no).
时间窗: Periprocedural.
Health education (use of nebulisers.), bronchial clearance sessions, positive pressure exercises (Acapella, Shaker), use of a volumetric spirometer, therapeutic exercise, strength training, aerobic training.
Treatment compliance
时间窗: Periprocedural.
Non-compliant category based on attendance records and adherence to sessions.
Lung function: spirometry.
时间窗: Periprocedural.
Spirometry is a respiratory function test that measures respiratory flow rates and volumes, which are useful for the diagnosis and monitoring of respiratory conditions. The spirometry results recorded in the medical records are compared: those taken before and after physiotherapy treatment.
Strength of the inspiratory muscles.
时间窗: Periprocedural
Measuring maximum inspiratory pressures (MIP) allows the strength of the inspiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating the maximum inspiratory pressure, measured in cmH₂O (starting from residual volume), against an occluded system. MIP primarily assesses diaphragmatic strength and is of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Strength of the expiratory muscles.
时间窗: Periprocedural
Measuring peak expiratory pressures (MEP) allows the strength of the expiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating maximum expiratory pressure (from total lung capacity) against an occluded system. MEP is measured in cmH₂O and primarily assesses the strength of the intercostal and abdominal muscles. MEP are of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Physical and functional capacity: The six-minute walk test (6MWT)
时间窗: Periprocedural.
The six-minute walk test (6MWT) is a functional assessment used to measure exercise capacity and the cardiorespiratory response to exertion under controlled conditions. It involves determining the maximum distance a person can walk on a flat surface over a period of six minutes. In addition, oxygen saturation is measured using pulse oximetry throughout the test. It is widely used to assess tolerance to physical exertion, monitor the progression of various respiratory conditions and estimate the functional prognosis of diseases in a clinical setting.
Physical and functional capacity : Sit-to-Stand Test (1STST)
时间窗: Periprocedural.
The Sit-to-Stand Test is a test that assesses the functional strength of the lower limbs and involves the person sitting down and standing up from a chair as many times as possible in 1 minute .
Physical and functional capacity : submaximal cycle ergometer test.
时间窗: Periprocedural.
A submaximal cycle ergometer test is a stress test carried out on a stationary bicycle in which the patient is not required to exert themselves to their maximum capacity. The aim is to assess the cardiovascular, respiratory and functional responses during moderate-intensity exercise. The following are measured: watts, the duration of the test and the reason for failure.
Physical and functional capacity: submaximal test on a treadmill
时间窗: Periprocedural
A submaximal treadmill test is a stress test carried out on a treadmill in which the patient walks at a moderate intensity, without reaching maximum exertion. Its aim is to assess the response to exercise and functional capacity in a safe manner. The duration of the test, the angle of inclination reached and the reason for giving up are measured.
Clinical findings
时间窗: Periprocedural.
An assessment is made as to whether the patient is experiencing a cough, sputum production or haemoptysis (yes/no) at the time of physiotherapy treatment.
次要结局
未报告次要终点
研究者
Yolanda Sanesteban Hermida
Physical Therapist in the Respiratory Physical Therapy Unit of the A Coruña University Hospital Complex
Fundación Pública Galega de Investigación Biomédica INIBIC