Thermotherapy Against Persistent Bacterial LUNG Infections (THERM-A-LUNG)
Lung Diseases, Obstructive, Bronchiectasis, Asthma
About this trial
This is an interventional treatment trial for Lung Diseases, Obstructive
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Competent and capable
- FEV1>1,0 L
- Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics
- Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months
Exclusion Criteria:
- Allergy to lidocaine and/or midazolam
- Contraindications to bronchoscopy
- Previous severe laryngospasm (intubation requiring)
- Pregnancy/breastfeeding
- Severe linguistic problems or inability to give informed consent
- Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others
Sites / Locations
- Herlev and Gentofte University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Thermotherapy/sauna bath
No thermotherapy/sauna bath
Must go to a sauna (min. Temperature 85℃) min. 4 times a week for 6 months. Each sauna bath must last at least 7 minutes. The intervention patients receive a subscription card for a sauna during the period. Patients will still receive pre-existing treatment
Not allowed to go to a sauna for 6 months. Patients who come to do so, by e.g. an oversight, however, remain in the study, to avoid introducing bias. It will be registered as a "protocol violation", but the patient will be included in Intention To Treat analysis and modified Intention To Treat analysis. Patients will still receive pre-existing treatment.