Clinical trial NCT05344300: Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases
Official title: Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Temperature Change, Body
Bronchiectasis
Heat Exposure
Heat
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung-healthy group: 5 persons will be recruited via bulletins in staff rooms and outpatient clinics at participating departments/hospitals.

Bronchiectasis group: 5 patients will be recruited via outpatient clinics at participating departments/hospitals.

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Changes in air temperature
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital
state: Copenhagen
Study officials:
References: