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RecruitingNCT07607977HMEPROUpdated Oct 29, 2026

Exploring Biomarkers in the Heat and Moisture Exchange Filters

An observational study in Respiratory Inflammation, sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Aalborg University Hospital · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Updated Oct 29, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Respiratory Inflammation

Keywords

  • exhaled breath proteomics
03

In context

Lead sponsor

Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥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.

Exclusion criteria

Exclusion Criteria:

  • Patients who are transferred to the ICU for continuous invasive mechanical ventilation after end of elective surgery.
  • Known chronic lung disease.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Elective surgery patients with expected mechanical ventialtion > 2 hours
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Through study completion, an average of 3 months.

Other outcomes

  1. Between-subject variation in exhaled breath protein concentration measured by proteomic analysis.

    Variation in protein concentration across HME filter samples collected from different participants, measured using protein quantification methods.

    Time frame: Through study completion, an average of 3 months.

07

Study locations

1 of 1 sites recruiting
  • Aalborg University Hospital
    Gistrup, 9260, Denmark
    Recruiting
    • Lise T Elkjær · Contactlit@rn.dk · +45 20 84 08 32
    • Bodil S Rasmussen, PhD · Sub investigator
    • Javier A Quezada, PhD · Sub investigator
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References and documents

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 40341493 ↗
  • Gade 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 37939397 ↗
  • McNeil 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 29253353 ↗
  • Bastarache 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 1, 2026→Jan 1, 2027
Oct 29, 2026
Study completion
May 1, 2027→Sep 1, 2027
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Primary completion Aug 1, 2026→Jan 1, 2027
    Study completion May 1, 2027→Sep 1, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07607977
Responsible party
Inger Lise Gade (Consultant, MD, PhD, Associate Professor, Aalborg University Hospital) — Principal investigator
First posted
May 27, 2026
Start date
May 8, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Inger L Gade, PhD
Contact
inlg@rn.dk
+45 20843941

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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