Respiratory InflammationHMEPRONCT07607977
Exploring Biomarkers in the Heat and Moisture Exchange Filters
An observational study of Respiratory Inflammation, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
When patients undergo major surgery, they are connected to a ventilator during anesthesia. A heat and moisture exchange filter (HME filter) is routinely placed in the ventilator tubing to ensure that the inhaled air is warm and humidified. Today, HME filters are used routinely in all ventilator treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Inflammation
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will include adult patients who are scheduled for elective surgery for non-malignant conditions under general anesthesia with invasive mechanical ventilation. The written and oral study information will be provided at the standard preoperative consultation with the anesthesiologist the day before elective surgery.
Who may be able to join
- ≥18 years, able to understand study information in Danish.
- Admitted for elective surgery for non-malignant conditions with either intravenous or inhalation anaesthesia and invasive mechanical ventilation according to standard practice.
- Expected invasive mechanical ventilation > 1 hour.
- Possess legal capacity.
- Informed, signed consent is obtained.
Who cannot join
- Patients who are transferred to the ICU for continuous invasive mechanical ventilation after end of elective surgery.
- Known chronic lung disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Gistrup, 9260
Lise T Elkjær, +45 20 84 08 32, lit@rn.dk
Bodil S Rasmussen, PhD
About this study
When patients undergo major surgery, they are connected to a ventilator during anesthesia. A heat and moisture exchange filter (HME filter) is routinely placed in the ventilator tubing to ensure that the inhaled air is warm and humidified. Today, HME filters are used routinely in all ventilator treatments. They are typically replaced once a day and discarded as regular waste after use.
The purpose of this study is to investigate whether HME filters contain proteins and small biological particles from the patient's exhaled air.
- Conditions
- Respiratory Inflammation
- Keywords
- exhaled breath proteomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective surgery patients with expected mechanical ventialtion > 2 hours | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total endogenous protein amount captured in HME filters measured by standard biochemical assays.
Quantification of the total amount of endogenous proteins recovered from heat moisture exchange (HME) filters using Biuret based analysis.
Measured: Through study completion, an average of 3 months.
Secondary outcomes (1)
Protein molecular weight and isoelectric point distribution in proteins captured by HME filters.
Distribution and representation of captured proteins according to molecular weight and isoelectric point characteristics determined by proteomic analysis.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start8 May 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory InflammationStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inger Lise Gade, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607977
- Sponsor's protocol ID
- F2025-193
- Other IDs
- N-20250044
- Acronym
- HMEPRO
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data analyses will be performed in our institution as only conventional biochemical analyses will be applied. No external collaborators are needed and hence the investigators have no need to share IPD outside the instutution.
Publications
Gade IL, Bodilsen J, Mariager T, Hertz S, Duerlund LS, Holm CK, Madsen PH, Bennike TB, Honore B. Exhaled breath protein composition in patients hospitalised during the first wave of COVID-19. J Breath Res. 2025 May 16;19(3). doi: 10.1088/1752-7163/add617.
PubMed 40341493Gade IL, Riddersholm SJ, Stilling-Vinther T, Brondum RF, Bennike TB, Honore B. A clinical proteomics study of exhaled breath condensate and biomarkers for pulmonary embolism. J Breath Res. 2023 Nov 17;18(1). doi: 10.1088/1752-7163/ad0aaa.
PubMed 37939397McNeil JB, Shaver CM, Kerchberger VE, Russell DW, Grove BS, Warren MA, Wickersham NE, Ware LB, McDonald WH, Bastarache JA. Novel Method for Noninvasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1027-1035. doi: 10.1164/rccm.201707-1474OC.
PubMed 29253353Bastarache JA, McNeil JB, Plosa EJ, Sucre JS, Kerchberger VE, Habegger LE, Weddle E, Sullivan B, Meegan JE, Wickersham NE, Shaver CM, Ware LB. Standardization of methods for sampling the distal airspace in mechanically ventilated patients using heat moisture exchange filter fluid. Am J Physiol Lung Cell Mol Physiol. 2021 May 1;320(5):L785-L790. doi: 10.1152/ajplung.00595.2020. Epub 2021 Mar 3.
PubMed 33655765
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biomarkers in the Heat and Moisture Exchange Filters
- ClinicalTrials.gov ID
- NCT07607977
- Acronym / sponsor ID
- HMEPRO / F2025-193
- Conditions
- Respiratory Inflammation
- Keywords
- exhaled breath proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When patients undergo major surgery, they are connected to a ventilator during anesthesia. A heat and moisture exchange filter (HME filter) is routinely placed in the ventilator tubing to ensure that the inhaled air is warm and humidified. Today, HME filters are used routinely in all ventilator treatments. They are typically replaced once a day and discarded as regular waste after use.
The purpose of this study is to investigate whether HME filters contain proteins and small biological particles from the patient's exhaled air.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective surgery patients with expected mechanical ventialtion > 2 hours | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will include adult patients who are scheduled for elective surgery for non-malignant conditions under general anesthesia with invasive mechanical ventilation. The written and oral study information will be provided at the standard preoperative consultation with the anesthesiologist the day before elective surgery.
Key inclusion criteria (5 listed)
- ≥18 years, able to understand study information in Danish.
- Admitted for elective surgery for non-malignant conditions with either intravenous or inhalation anaesthesia and invasive mechanical ventilation according to standard practice.
- Expected invasive mechanical ventilation > 1 hour.
- Possess legal capacity.
- Informed, signed consent is obtained.
Key exclusion criteria (2 listed)
- Patients who are transferred to the ICU for continuous invasive mechanical ventilation after end of elective surgery.
- Known chronic lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total endogenous protein amount captured in HME filters measured by standard biochemical assays.
Time frame: Through study completion, an average of 3 months.
Quantification of the total amount of endogenous proteins recovered from heat moisture exchange (HME) filters using Biuret based analysis.
1 secondary outcome
Protein molecular weight and isoelectric point distribution in proteins captured by HME filters.
Time frame: Through study completion, an average of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 40341493Gade IL, Bodilsen J, Mariager T, Hertz S, Duerlund LS, Holm CK, Madsen PH, Bennike TB, Honore B. Exhaled breath protein composition in patients hospitalised during the first wave of COVID-19. J Breath Res. 2025 May 16;19(3). doi: 10.1088/1752-7163/add617.
- Background: PubMed 37939397Gade IL, Riddersholm SJ, Stilling-Vinther T, Brondum RF, Bennike TB, Honore B. A clinical proteomics study of exhaled breath condensate and biomarkers for pulmonary embolism. J Breath Res. 2023 Nov 17;18(1). doi: 10.1088/1752-7163/ad0aaa.
- Background: PubMed 29253353McNeil JB, Shaver CM, Kerchberger VE, Russell DW, Grove BS, Warren MA, Wickersham NE, Ware LB, McDonald WH, Bastarache JA. Novel Method for Noninvasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1027-1035. doi: 10.1164/rccm.201707-1474OC.
- Background: PubMed 33655765Bastarache JA, McNeil JB, Plosa EJ, Sucre JS, Kerchberger VE, Habegger LE, Weddle E, Sullivan B, Meegan JE, Wickersham NE, Shaver CM, Ware LB. Standardization of methods for sampling the distal airspace in mechanically ventilated patients using heat moisture exchange filter fluid. Am J Physiol Lung Cell Mol Physiol. 2021 May 1;320(5):L785-L790. doi: 10.1152/ajplung.00595.2020. Epub 2021 Mar 3.
- Individual participant dataSharing planned: No. All data analyses will be performed in our institution as only conventional biochemical analyses will be applied. No external collaborators are needed and hence the investigators have no need to share IPD outside the instutution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Inflammation, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inger L Gade, PhD (+45 20843941, inlg@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total endogenous protein amount captured in HME filters measured by standard biochemical assays. (time frame: Through study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607977, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.