Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases

Bronchiectasis Clinical Trial

— TEMP-REC-LUNG  

Official title:

Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05344300
• Other study ID #: TEMP-REC-LUNG
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Bronchiectasis
• Heat
• Heat Exposure
• Temperature Change, Body

Intervention

Other:
• Temperature-measurement in lungs under sauna bath
Through a bronchoscopy procedure under an 88-92? environment, the air temperature is measured in the 1st, 2nd and 3rd bronchial segment, at 4th and 5th bronchial segment and at 6th-10th bronchial segment in resp. the right and left lung. The temperature is measured at time: 0 seconds (s), 15 s, 30 s, 45 s, 60 s, 75 s, 90 s, 105 s, 120 s, 135 s and 150 s.

Locations

Country	Name	City	State
Denmark	Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital	Gentofte	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in air temperature	Changes in air temperature (under 88-92? surroundings) measured in both lungs at 1st, 2nd and 3rd bronchial segment, at 4th and 5th bronchial segment and at 6th-10th. bronchial segment at times 0 s, 15 s, 30 s, 45 s, 60 s, 75 s, 90 s, 105 s, 120 s, 135 s, and 150 s.	1 day