Effects of Information and Breathing Technique - for Patients With Respiratory Associated Chest Pain in Acute Pulmonary Embolism. A Randomized, Controlled Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Analgesic consumption
研究概览
简要总结
Acute pulmonary embolism (PE) is a serious disease and the third most common cardiovascular disease following myocardial infarction and stroke. The most common symptoms of acute PE are breathlessness and respiratory pain. Although many patients have respiratory pain in acute PE, the treatment of pain is not well described in literature. It is also unclear how long after acute PE the respiratory pain persists. In other conditions with respiratory associated pain, clinical treatment guidelines are available to avoid complications, such as pneumonia, related to impaired respiratory function.
The purpose of this randomized controlled multicenter study is to evaluate the effect of a treatment, in patients with respiratory associated acute PE pain, consisting of information on anatomy and physiology in acute PE and breathing technique in addition to usual care treatment. The above treatment will be compared to conventional treatment in PE with respiratory associated pain, which means treatment with analgesics.
One hundred sixty patients recruited from the Sahlgrenska University Hospital and Alingsås Hospital will participate in the study.
Both groups are examined before and after interventions related to respiratory associated pain, measured with visual analogue scale (VAS), analgesic consumption, lung function measured with Peak Expiratory Flow (PEF), physical disability impairment measured by Disability Rating Index (DRI) and questions about the patients self-efficacy on managing their respiratory associated pain, days hospitalized, pneumonia rate during or after hospitalization, oxygen saturation and patient satisfaction.
Both groups are followed from the inclusion date to 14 days after inclusion through physical visits by the physiotherapist during hospital care and by telephone contact after discharge.
If the positive clinical experience of the information and breathing technique can be confirmed in the study, the method could be spread and used as an easily accessible new treatment method.
详细描述
Acute pulmonary embolism (PE) is one of the manifestations of venous thromboembolism (VTE) and is a serious and potentially life threatening condition. VTE is the third most common cardiovascular disease after myocardial infarction and stroke, and in the West, with its aging population, a major health problem. In Sweden, the number of diagnosed cases of acute PE is 20-60 per 100,000 inhabitants per year.
The most common symptoms of acute PE are breathlessness and respiratory associated pain. The respiratory pain is an inflammatory pain that originates from the vessels where the embolisms are located. The pain occurs through an irritation of the visceral pleural membrane and creates a sharp, clearly localized pain that increases during deep breathing, coughing and in some cases in motion.
The National Board of Health and Welfare in Sweden´s guidelines for the treatment of venous thromboembolism state that "thrombosis can cause acute pain and the disease may generate anxiety especially in respiratory symptoms". It is unclear how long the pain persists. In a previous study of our research group, 30% of patients had residual respiratory associated pain at discharge after being treated for acute PE.
Although many patients have respiratory associated pain in acute PE, there are no clear description of how this pain should be treated in current guidelines internationally and nationally in Sweden.
Evidence exists that patients with respiratory pain for example after surgery or after costae fracture, should use breathing exercises to increase their ventilation and reduce the risk of complications such as pneumonia and atelectasis.The exercise consists of deep breathing exercise focusing on exhalation with a positive expiratory pressure-device or breathing exercise focused on inhalation with an inhalation spirometer, which has been shown to reduce pleural pressure, increase lung expansion and provide better gas exchange. As far as we know, there are currently no studies on the treatment of respiratory related pain in acute PE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18 and 80 years of age that understands oral and written instructions in Swedish
- •Presence of respiratory associated chest pain from a verified acute pulmonary embolism.
- •Presence of respiratory associated pain after moving from a lying to a seated position and taken three deep breaths
- •At the time of assessment of pain estimate his/hers pain to >30 mm on the Visual Analogue Scale.
排除标准
- •Serious physical illness that includes thorax ie. trauma, lung cancer or rheumatological disease
- •Serious non-treated psychiatric disease including psychiatric and psychological disease which are the main cause to the patients pain
- •Severe alcohol- or substance abuse
- •Treatment with opioids before the diagnosis of acute pulmonary embolism. -Prolonged cancer/ non-cancer related pain.
研究组 & 干预措施
Information on anatomy and physiology, and breathing technique
Information on anatomy and physiology, and breathing technique
- Information about anatomy
- Information about physiology
- Breathing technique
干预措施: Information on anatomy and physiology, and breathing technique (Other)
Usual care treatment
Usual care treatment given to patients with respiratory associated pain in acute PE, which is treatment with analgesics. The information on anatomy and physiology in acute PE is the usual information given by the physician at the ward that the patient is treated.
干预措施: Usual care treatment (Other)
结局指标
主要结局
Analgesic consumption
时间窗: Daily during the whole study period of 14 days.
Daily consumption of analgesics is recorded in the study protocol via the patient record. When the patient is discharged from hospital, the patient registers what type of analgesics the patient has taken and in what amount in the study protocol.
Respiratory associated pain estimated with Visual Analogue Scale (VAS).
时间窗: Daily during the whole study period of 14 days.
Self-assessment of pain intensity of respiratory associated pain according to VAS (scale 0-10, "no pain" vs. "worst possible pain"). Pain intensity is estimated by the patient after moving from lying to sitting and taking three deep breaths. Estimation once a day of average pain during the day is estimated throughout the entire study period. VAS is an instrument for self-estimation of pain which in studies has proven to be both valid and reliable in estimating acute pain.
次要结局
- Lung function measurement with Peak Expiratory Flow (PEF)(Measurement takes place on the day of inclusion and at the day for discharge from hospital. If the patient is not discharged within 14 days, the measurement takes place at day 14.)
- Functional index estimated with Disability Rating Index (DRI).(Estimation takes place on the day of inclusion, day 7 and day 14.)
- Frequency use of breathing technique.(Daily during the whole study period of 14 days.)
- Questions about patients self-efficacy on coping with pain(The questions are asked by a protocol on the day of inclusion, day 7 and day 14.)