Exploring Biomarkers in the Heat and Moisture Exchange Filters

NCT07607977 | Recruiting

• 2 other identifiers: F2025-193N-20250044
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Inflammation

Keywords

exhaled breath proteomics

Outcome Measures

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.

  Through study completion, an average of 3 months.

Secondary Outcomes (1)

• Protein molecular weight and isoelectric point distribution in proteins captured by HME filters.

  Through study completion, an average of 3 months.

Other Outcomes (1)

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

  Through study completion, an average of 3 months.

Study Arms (1)

Elective surgery patients with expected mechanical ventialtion > 2 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Gistrup, 9260, Denmark

RECRUITING

Related Publications (4)

• 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.

  PMID: 40341493 BACKGROUND

• 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.

  PMID: 37939397 BACKGROUND

• 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.

  PMID: 29253353 BACKGROUND

• 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.

  PMID: 33655765 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath droplets contained in the HME filter puls two blood samples to correlate findings in HME filters with blood levels.

Central Study Contacts

Inger L Gade, PhD

CONTACT

+45 20843941; inlg@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, PhD, Associate Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 27, 2026
• Study Start: May 8, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)