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| ID | Type | Description | Link |
|---|---|---|---|
| N-20250044 | Other Identifier | North Denmark Regional Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective surgery patients with expected mechanical ventialtion > 2 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 3 months. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inger L Gade, PhD | Contact | +45 20843941 | inlg@rn.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Gistrup | 9260 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40341493 | Background | 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. | |
| 37939397 | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2025 | May 14, 2026 | Prot_000.pdf |
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Exhaled breath droplets contained in the HME filter puls two blood samples to correlate findings in HME filters with blood levels.
| 29253353 | 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. |
| 33655765 | 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. |