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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiectasis; Temperature Change, Body; Heat; Heat Exposure
• Intervention / Treatment: Other: Temperature-measurement in lungs under sauna bath

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Gentofte, Copenhagen, Denmark, 2900
      • Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung-healthy group	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.
Bronchiectasis group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Body Temperature Changes
• Other Study ID Numbers: TEMP-REC-LUNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No