Pulmonary Embolism Clinical Trial
Official title:
Effects of Information and Breathing Technique - for Patients With Respiratory Associated Chest Pain in Acute Pulmonary Embolism. A Randomized, Controlled Multicenter Study.
Verified date | February 2024 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Göteborg | Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Days hospitalized | Registration on how many days the patient has been admitted to hospital care due to acute pulmonary embolism. | Registration of the outcome takes place at the day for discharge from hospital with a maximal admission time of 14 days. | |
Other | Pneumonia frequency | The rate of patients that develops a pneumonia after having acute pulmonary embolism. | The patient is asked if he/she have had a pneumonia after falling ill with acute pulmonary embolism. The question is asked at day 14 over the telephone through a Day-14-follow-up-protocol. | |
Other | Oxygen saturation of the blood | Registration of the patients oxygen saturation by a puls oximeter device. | Daily, once a day during hospitalization. If the time hospitalized exceeds 14 days then the last day for registration is day 14. | |
Primary | Respiratory associated pain estimated with Visual Analogue Scale (VAS). | 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. | Daily during the whole study period of 14 days. | |
Primary | Analgesic consumption | 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. | Daily during the whole study period of 14 days. | |
Secondary | Frequency use of breathing technique. | Patients in the treatment group register the frequency of the use of the breathing technique during the whole day. The registration of breathing techniques is divided into sections where, 1-3 times, 4-6 times, 7-10 times or more than 11 times a day, are the different options. Measurement once a day throughout the study period. |
Daily during the whole study period of 14 days. | |
Secondary | Lung function measurement with Peak Expiratory Flow (PEF) | A measurement of the patient's ability to breathe out his/hers air three times is tested using a PEF-device. The measurement is an objective measure of the patient's ability to create a maximum airflow value during expiration, which may identify possible airway obstruction. | 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. | |
Secondary | Questions about patients self-efficacy on coping with pain | Patients will respond to three claims of confidence in their own ability to cope with their pain. The claims are rated from "Not sure" to "Absolutely safe" on a 100-millimeter horizontal line and are: How sure are you on your ability to reduce your respiratory associated pain significantly? How sure are you that you can achieve a small to moderate decrease in your respiratory associated pain by means other than increased medication? How sure are you that you can achieve a significant reduction in your respiratory associated pain by means other than increased medication? The questions used are chosen from a scale of self-efficacy and are used exploratively to seek more knowledge of the patients own experience of managing the pain associated with acute LE. |
The questions are asked by a protocol on the day of inclusion, day 7 and day 14. | |
Secondary | Functional index estimated with Disability Rating Index (DRI). | The patient estimates his/hers perceived physical impairment in performing twelve different physical activities from making simpler activities to exercise physically strenuous activities. The patient estimates his ability to perform the activity from "manage without difficulty" to "unable to perform" on a horizontal line that is 100 mm long. DRI is an instrument commonly used for patients with musculoskeletal disabilities. For this patient group, DRI has proven to have both high validity and reliability. DRI has also been used for patients with stable coronary artery disease and has also demonstrated good reliability in the assessment of physical function. |
Estimation takes place on the day of inclusion, day 7 and day 14. |
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