Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases

NCT05344300 | Unknown DMC

• 1 other identifier: TEMP-REC-LUNG
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body; Bronchiectasis; Heat Exposure; Heat

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lung-healthy group

Other: Temperature-measurement in lungs under sauna bath

Bronchiectasis group

Other: Temperature-measurement in lungs under sauna bath

Interventions

Temperature-measurement in lungs under sauna bath OTHER

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; Lung-healthy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• Age ≥ 18 years
• Competent and capable
• FEV1\>1,0 L
• Have diagnosed bronchiectasis \[radiology verified and evaluated by pulmonary specialist\]
• Allergy to lidocaine and/or midazolam
• Contraindications to bronchoscopy\*
• Previous severe laryngospasm (intubation requiring)
• Pregnancy/breastfeeding

Sponsors & Collaborators

• Chronic Obstructive Pulmonary Disease Trial Network, Denmark: lead

Study Sites (1)

Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital

Gentofte Municipality, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Body Temperature Changes; Bronchiectasis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)