Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases (TEMP-REC-LUNG)

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status: Active, not recruiting

Conditions: Heat; Heat Exposure; Bronchiectasis; Temperature Change, Body

Treatments: Other: Temperature-measurement in lungs under sauna bath

Study type: Observational

Funder types: Other

Identifiers

NCT05344300

TEMP-REC-LUNG

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

10 participants in 2 patient groups

Lung-healthy group

Treatment:

Other: Temperature-measurement in lungs under sauna bath

Bronchiectasis group

Treatment:

Other: Temperature-measurement in lungs under sauna bath