Video Assisted Thoracic Surgery (VATS)NCT07729319
Clinical Effects of Intraoperative Heat and Moisture Exchange Systems During Thoracic Surgery: A Prospective Observational Cohort Study
An observational study of Video Assisted Thoracic Surgery (VATS) and Postoperative Complications, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
General anesthesia with endotracheal intubation bypasses the physiological warming and humidification functions of the upper airway, allowing cold and dry gases to reach the lower respiratory tract. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Video Assisted Thoracic Surgery (VATS), Postoperative Complications, Pulmonary Complications in Surgical Patients
- What is being tested?
- Active Heated Humidification and Heat and Moisture Exchanger
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2026to Apr 2027
- How long will I take part?
- 7 Days
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective video-assisted thoracoscopic lung resection requiring one-lung ventilation at Marmara University Pendik Training and Research Hospital.
Who may be able to join
- Patients aged 18 to 75 years
- Elective video-assisted thoracoscopic surgery (VATS)
- Lung resection requiring general anesthesia
- Planned one-lung ventilation
- Written informed consent
Who cannot join
- Emergency surgery
- Pregnancy
- Preoperative mechanical ventilation
- Previous enrollment
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, Istanbul, 34722
Nezaket Nur Arslan Kömür, MD, +905392911654, nnurarslan@gmail.com
Seniyye Ülgen Zengin, Associate Professor, MD, +905057142443, ulgen_t@yahoo.com
About this study
Official title: Clinical Effects of Active Versus Passive Intraoperative Respiratory Gas Humidification During Video-Assisted Thoracoscopic Surgery: A Prospective Single-Center Observational Cohort Study
General anesthesia with endotracheal intubation bypasses the physiological warming and humidification functions of the upper airway, allowing cold and dry gases to reach the lower respiratory tract. This may impair mucociliary clearance, increase secretion viscosity, promote atelectasis, and contribute to postoperative pulmonary complications (PPCs).
Patients undergoing thoracic surgery, particularly those requiring one-lung ventilation (OLV), are at increased risk for PPCs because of altered ventilation-perfusion matching, reduced functional residual capacity, and impaired secretion clearance. Although respiratory gas humidification is routinely used during anesthesia, evidence regarding the comparative clinical effects of active heated humidification (AHH) and passive heat and moisture exchangers (HMEs) during thoracic surgery remains limited.
This prospective observational cohort study aims to evaluate the association between intraoperative respiratory gas humidification methods and postoperative pulmonary complications and perioperative clinical outcomes in adult patients undergoing elective video-assisted thoracoscopic surgery (VATS).
Read the detailed description
The physiological conditioning of inspired gases is bypassed during general anesthesia with endotracheal intubation. Delivery of inadequately heated and humidified gases to the lower respiratory tract may impair mucociliary function, increase secretion viscosity, reduce airway patency, and promote postoperative pulmonary complications.
Patients undergoing video-assisted thoracoscopic surgery (VATS) frequently require one-lung ventilation, which further increases susceptibility to pulmonary complications through ventilation-perfusion mismatch, impaired secretion clearance, and atelectasis formation.
Two principal approaches are used for intraoperative respiratory gas conditioning:
Passive heat and moisture exchangers (HMEs) Active heated humidification systems (AHHs) Although HMEs are widely used because of their simplicity, they may provide insufficient humidification during prolonged procedures, high minute ventilation, or one-lung ventilation. Active heated humidifiers deliver gases closer to physiological conditions (approximately 37°C and 100% relative humidity), potentially reducing secretion viscosity and improving airway patency.
Most existing studies evaluating respiratory gas humidification have focused on intensive care patients receiving prolonged mechanical ventilation. Evidence regarding thoracic surgical patients remains limited, particularly during one-lung ventilation.
This prospective, single-center observational cohort study will compare perioperative outcomes among patients managed with active or passive humidification according to routine anesthetic practice. No intervention or randomization will be performed.
- Conditions
- Video Assisted Thoracic Surgery (VATS), Postoperative Complications, Pulmonary Complications in Surgical Patients, Humidification, Air Conditioning
- Being tested
- Active Heated Humidification, Heat and Moisture Exchanger
- Keywords
- VATS, Postoperative complications, Humidification, Thoracic Surgery, Pulmonary Complications, One-Lung Ventilation, Heat and Moisture Exchanger, HME, Air Conditioning
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Heated HumidificationDevice
An active heated humidification system integrated into the anesthesia breathing circuit is used during intraoperative mechanical ventilation to warm and humidify inspired respiratory gases. Device selection and clinical management are determined solely by the attending anesthesiologist according to institutional routine practice. No study-specific intervention or modification of patient care is performed.
Heat and Moisture ExchangerDevice
A passive heat and moisture exchanger filter is incorporated into the anesthesia breathing circuit during intraoperative mechanical ventilation to conserve heat and moisture from exhaled gases. Device selection is based on routine clinical practice, and no intervention is assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Active Heated Humidification (AHH) | Patients receiving active heated respiratory gas humidification during intraoperative mechanical ventilation according to routine clinical practice. Receives: Device: Active Heated Humidification | |
| Heat and Moisture Exchanger (HME) | Patients receiving passive heat and moisture exchanger filters during intraoperative mechanical ventilation according to routine clinical practice. Receives: Device: Heat and Moisture Exchanger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Pulmonary Complications
Incidence of one or more postoperative pulmonary complications occurring within 7 days after surgery, including atelectasis, pneumonia, secretion retention, bronchoscopy for mucus plugging, prolonged oxygen requirement, requirement for non-invasive or invasive ventilatory support, or reintubation. PPCs will be assessed using predefined clinical and radiological criteria.
Measured: From completion of surgery through postoperative Day 7.
Secondary outcomes (11)
Oxygenation (PaO₂/FiO₂ Ratio)
Intraoperative arterial oxygenation assessed by the ratio of arterial oxygen partial pressure (PaO₂) to the fraction of inspired oxygen (FiO₂).
Measured: Measured during one-lung ventilation and at the end of surgery.
Frequency of Endotracheal Suctioning
Number of endotracheal suctioning procedures performed during the intraoperative period.
Measured: From induction of anesthesia until completion of surgery.
Airway Secretion Viscosity Score
Airway secretion viscosity assessed using a semi-quantitative 5-point scale (0 = no secretions, 1 = watery secretions, 2 = mildly viscous secretions, 3 = thick secretions difficult to aspirate, 4 = very thick obstructive secretions). The highest score recorded for each patient will be used for analysis.
Measured: During one-lung ventilation, at the end of one-lung ventilation, and within 24 hours after extubation.
Incidence of Intraoperative Hypothermia
Proportion of patients developing intraoperative hypothermia, defined as a core body temperature <36.0°C.
Measured: From induction of anesthesia until completion of surgery.
Incidence of Postoperative Hypothermia
Proportion of patients with body temperature <36.0°C during postoperative monitoring.
Measured: Within the first 24 hours after surgery.
Postoperative Oxygen Therapy Requirement
Requirement for supplemental oxygen after surgery.
Measured: Within the first 72 hours after surgery.
Requirement for Non-invasive Ventilation
Requirement for postoperative non-invasive ventilatory support.
Measured: Within the first 72 hours after surgery.
Intensive Care Unit Length of Stay
Duration of admission to the intensive care unit.
Measured: From ICU admission until ICU discharge, up to postoperative Day 30.
Hospital Length of Stay
Length of hospitalization measured from the date of surgery until hospital discharge.
Measured: From surgery until hospital discharge, up to postoperative Day 30.
Bronchodilator Therapy Requirement
Proportion of patients requiring bronchodilator treatment during the postoperative period.
Measured: Within 7 days after surgery.
C-Reactive Protein (CRP)
Serum C-reactive protein concentration as a marker of postoperative inflammatory response.
Measured: Postoperative Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracic Surgery (VATS)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- 200 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulgen Zengin, Marmara University
- Investigators
- Nezaket Nur Arslan Kömür, MD, Study chair, Marmara UniversitySeniyye Ülgen Zengin, Associate Professor, Principal investigator, Marmara UniversityMeliha Orhon Ergün, Associate Professor, MD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729319
- Sponsor's protocol ID
- 09.2026.26-0220
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Active Versus Passive Intraoperative Respiratory Gas Humidification During Video-Assisted Thoracoscopic Surgery: A Prospective Single-Center Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07729319
- Acronym / sponsor ID
- 09.2026.26-0220
- Conditions
- Video Assisted Thoracic Surgery (VATS), Postoperative Complications, Pulmonary Complications in Surgical Patients, Humidification, Air Conditioning
- Keywords
- VATS, Postoperative complications, Humidification, Thoracic Surgery, Pulmonary Complications, One-Lung Ventilation, Heat and Moisture Exchanger, HME
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Jul 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.
General anesthesia with endotracheal intubation bypasses the physiological warming and humidification functions of the upper airway, allowing cold and dry gases to reach the lower respiratory tract. This may impair mucociliary clearance, increase secretion viscosity, promote atelectasis, and contribute to postoperative pulmonary complications (PPCs).
Patients undergoing thoracic surgery, particularly those requiring one-lung ventilation (OLV), are at increased risk for PPCs because of altered ventilation-perfusion matching, reduced functional residual capacity, and impaired secretion clearance. Although respiratory gas humidification is routinely used during anesthesia, evidence regarding the comparative clinical effects of active heated humidification (AHH) and passive heat and moisture exchangers (HMEs) during thoracic surgery remains limited.
This prospective observational cohort study aims to evaluate the association between intraoperative respiratory gas humidification methods and postoperative pulmonary complications and perioperative clinical outcomes in adult patients undergoing elective video-assisted thoracoscopic surgery (VATS).
Detailed description
The physiological conditioning of inspired gases is bypassed during general anesthesia with endotracheal intubation. Delivery of inadequately heated and humidified gases to the lower respiratory tract may impair mucociliary function, increase secretion viscosity, reduce airway patency, and promote postoperative pulmonary complications.
Patients undergoing video-assisted thoracoscopic surgery (VATS) frequently require one-lung ventilation, which further increases susceptibility to pulmonary complications through ventilation-perfusion mismatch, impaired secretion clearance, and atelectasis formation.
Two principal approaches are used for intraoperative respiratory gas conditioning:
Passive heat and moisture exchangers (HMEs) Active heated humidification systems (AHHs) Although HMEs are widely used because of their simplicity, they may provide insufficient humidification during prolonged procedures, high minute ventilation, or one-lung ventilation. Active heated humidifiers deliver gases closer to physiological conditions (approximately 37°C and 100% relative humidity), potentially reducing secretion viscosity and improving airway patency.
Most existing studies evaluating respiratory gas humidification have focused on intensive care patients receiving prolonged mechanical ventilation. Evidence regarding thoracic surgical patients remains limited, particularly during one-lung ventilation.
This prospective, single-center observational cohort study will compare perioperative outcomes among patients managed with active or passive humidification according to routine anesthetic practice. No intervention or randomization will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Heated Humidification (AHH) | – | Device: Active Heated HumidificationPatients receiving active heated respiratory gas humidification during intraoperative mechanical ventilation according to routine clinical practice. |
| Heat and Moisture Exchanger (HME) | – | Device: Heat and Moisture ExchangerPatients receiving passive heat and moisture exchanger filters during intraoperative mechanical ventilation according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective video-assisted thoracoscopic lung resection requiring one-lung ventilation at Marmara University Pendik Training and Research Hospital.
Key inclusion criteria (5 listed)
- Patients aged 18 to 75 years
- Elective video-assisted thoracoscopic surgery (VATS)
- Lung resection requiring general anesthesia
- Planned one-lung ventilation
- Written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- Pregnancy
- Preoperative mechanical ventilation
- Previous enrollment
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Heated HumidificationAn active heated humidification system integrated into the anesthesia breathing circuit is used during intraoperative mechanical ventilation to warm and humidify inspired respiratory gases. Device selection and clinical management are determined solely by the attending anesthesiologist according to institutional routine practice. No study-specific intervention or modification of patient care is performed. | Device | Active Heated Humidification (AHH) |
| Heat and Moisture ExchangerA passive heat and moisture exchanger filter is incorporated into the anesthesia breathing circuit during intraoperative mechanical ventilation to conserve heat and moisture from exhaled gases. Device selection is based on routine clinical practice, and no intervention is assigned by the study protocol. | Device | Heat and Moisture Exchanger (HME) |
Primary outcome
Incidence of Postoperative Pulmonary Complications
Time frame: From completion of surgery through postoperative Day 7.
Incidence of one or more postoperative pulmonary complications occurring within 7 days after surgery, including atelectasis, pneumonia, secretion retention, bronchoscopy for mucus plugging, prolonged oxygen requirement, requirement for non-invasive or invasive ventilatory support, or reintubation. PPCs will be assessed using predefined clinical and radiological criteria.
11 secondary outcomes
Oxygenation (PaO₂/FiO₂ Ratio)
Time frame: Measured during one-lung ventilation and at the end of surgery.
Frequency of Endotracheal Suctioning
Time frame: From induction of anesthesia until completion of surgery.
Airway Secretion Viscosity Score
Time frame: During one-lung ventilation, at the end of one-lung ventilation, and within 24 hours after extubation.
Incidence of Intraoperative Hypothermia
Time frame: From induction of anesthesia until completion of surgery.
Incidence of Postoperative Hypothermia
Time frame: Within the first 24 hours after surgery.
Postoperative Oxygen Therapy Requirement
Time frame: Within the first 72 hours after surgery.
Requirement for Non-invasive Ventilation
Time frame: Within the first 72 hours after surgery.
Intensive Care Unit Length of Stay
Time frame: From ICU admission until ICU discharge, up to postoperative Day 30.
Hospital Length of Stay
Time frame: From surgery until hospital discharge, up to postoperative Day 30.
Bronchodilator Therapy Requirement
Time frame: Within 7 days after surgery.
C-Reactive Protein (CRP)
Time frame: Postoperative Day 7.
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 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
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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.
Nezaket Nur Arslan Kömür, MD study chair
Marmara University
Seniyye Ülgen Zengin, Associate Professor principal investigator
Marmara University
Meliha Orhon Ergün, Associate Professor, MD study director
Marmara University
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 Video Assisted Thoracic Surgery (VATS) and Postoperative Complications, run by Marmara University at 1 site in Turkey (Türkiye).
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 5 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 27 Jul 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 Turkey (Türkiye). 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 Nezaket Nur Arslan Kömür, MD (+905392911654, nnurarslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pulmonary Complications (time frame: From completion of surgery through postoperative Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.