Temperature Recording in Lungs of Volunteers With and Wit... | NCT05344300

Studies
Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases

NCT05344300

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status

Unknown status

Last Update Posted

Sep 1, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Temperature Change, Body
Bronchiectasis
Heat Exposure
Heat

Interventions

Temperature-measurement in lungs under sauna bath

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Apr 2024Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Apr 19, 2022

First Submission Date that Met QC Criteria

Apr 19, 2022

First Posted Date

Apr 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2023

Last Update Posted Date

Sep 1, 2023Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung-healthy group			Other: Temperature-measurement in lungs under sauna bath
Bronchiectasis group			Other: Temperature-measurement in lungs under sauna bath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D001832	Body Temperature Changes
D001987	Bronchiectasis

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases