| Registry | NCT05344300, acronym TEMP-REC-LUNG |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 10 (Estimated) |
| Sponsor | Chronic Obstructive Pulmonary Disease Trial Network, Denmark (Other) |
| Conditions | Temperature Change, Body, Bronchiectasis, Heat Exposure, Heat |
| Interventions | Temperature-measurement in lungs under sauna bath (Other) |
| Dates | start 2022-09-01, primary completion 2024-04-01 (estimated), completion 2025-09-01 (estimated), first posted 2022-04-25, last updated 2023-09-01 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Temperature Change, Body All trials for Bronchiectasis All trials of Temperature-measurement in lungs under sauna bath
The purpose of the project is to estimate the air temperature in the lungs after a change from room temperature (25℃) to an environment with a constant temperature of 88-92℃ in resp. lung-healthy persons and persons with bronchiectasis.
Heat is a widely available therapeutic modality and is often used for recovery after physical activity and pain treatment, and sauna bathing is a form of whole body thermotherapy ranging from 80-100 ℃ and low humidity of 10-20%. The heat load in a sauna has been shown to activate several beneficial physiological effects, and no adverse effects on the lungs have been demonstrated. It is unknown how much the air temperature in the lower respiratory tract (bronchial tree) in humans rises to under surroundings of 88-92℃.
This is an observational, clinical trial investigating the changes in air temperature at different bronchial segments in both lungs under surroundings of 88-92℃ resp. in lung-healthy persons and persons with bronchiectasis.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Lung-healthy group | Other: Temperature-measurement in lungs under sauna bath | ||
| Bronchiectasis group | Other: Temperature-measurement in lungs under sauna bath |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Lung-healthy group: Inclusion criteria: * Age ≥ 18 years * Competent and capable * Forced expiratory volume in the first second (FEV1)>1,0 L * Does not suffer from bronchiectasis, asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, sarcoidosis, active lung infection (past 30 days) or lung cancer 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 Bronchiectasis group: Inclusion criteria: * Age ≥ 18 years * Competent and capable * FEV1>1,0 L * Have diagnosed bronchiectasis \[radiology verified and evaluated by pulmonary specialist\] 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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital | Gentofte Municipality, Copenhagen | Denmark |