- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07729319
Clinical Effects of Intraoperative Heat and Moisture Exchange Systems During Thoracic Surgery: A Prospective Observational Cohort Study
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Seniyye Ülgen Zengin, Associate Professor, MD
- Phone Number: +905057142443
- Email: ulgen_t@yahoo.com
Study Contact Backup
- Name: Nezaket Nur Arslan Kömür, MD
- Phone Number: +905392911654
- Email: nnurarslan@gmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34722
- Recruiting
- Marmara University
-
Contact:
- Seniyye Ülgen Zengin, Associate Professor, MD
- Phone Number: +905057142443
- Email: ulgen_t@yahoo.com
-
Principal Investigator:
- Seniyye Ülgen Zengin, Associate Professor, MD
-
Sub-Investigator:
- Meliha Orhon Ergün, Associate Professor, MD
-
Contact:
- Nezaket Nur Arslan Kömür, MD
- Phone Number: +905392911654
- Email: nnurarslan@gmail.com
-
Sub-Investigator:
- Nezaket Nur Arslan Kömür, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 to 75 years
- Elective video-assisted thoracoscopic surgery (VATS)
- Lung resection requiring general anesthesia
- Planned one-lung ventilation
- Written informed consent
Exclusion Criteria:
- Emergency surgery
- Pregnancy
- Preoperative mechanical ventilation
- Previous enrollment
- Refusal to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Active Heated Humidification (AHH)
Patients receiving active heated respiratory gas humidification during intraoperative mechanical ventilation according to routine clinical practice.
|
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 Exchanger (HME)
Patients receiving passive heat and moisture exchanger filters during intraoperative mechanical ventilation according to routine clinical practice.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From completion of surgery through postoperative Day 7.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygenation (PaO₂/FiO₂ Ratio)
Time Frame: Measured during one-lung ventilation and at the end of surgery.
|
Intraoperative arterial oxygenation assessed by the ratio of arterial oxygen partial pressure (PaO₂) to the fraction of inspired oxygen (FiO₂).
|
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.
|
Number of endotracheal suctioning procedures performed during the intraoperative period.
|
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.
|
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.
|
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.
|
Proportion of patients developing intraoperative hypothermia, defined as a core body temperature <36.0°C.
|
From induction of anesthesia until completion of surgery.
|
|
Incidence of Postoperative Hypothermia
Time Frame: Within the first 24 hours after surgery.
|
Proportion of patients with body temperature <36.0°C during postoperative monitoring.
|
Within the first 24 hours after surgery.
|
|
Postoperative Oxygen Therapy Requirement
Time Frame: Within the first 72 hours after surgery.
|
Requirement for supplemental oxygen after surgery.
|
Within the first 72 hours after surgery.
|
|
Requirement for Non-invasive Ventilation
Time Frame: Within the first 72 hours after surgery.
|
Requirement for postoperative non-invasive ventilatory support.
|
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.
|
Duration of admission to the intensive care unit.
|
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.
|
Length of hospitalization measured from the date of surgery until hospital discharge.
|
From surgery until hospital discharge, up to postoperative Day 30.
|
|
Bronchodilator Therapy Requirement
Time Frame: Within 7 days after surgery.
|
Proportion of patients requiring bronchodilator treatment during the postoperative period.
|
Within 7 days after surgery.
|
|
C-Reactive Protein (CRP)
Time Frame: Postoperative Day 7.
|
Serum C-reactive protein concentration as a marker of postoperative inflammatory response.
|
Postoperative Day 7.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Meliha Orhon Ergün, Associate Professor, MD, Marmara University
- Study Chair: Nezaket Nur Arslan Kömür, MD, Marmara University
- Principal Investigator: Seniyye Ülgen Zengin, Associate Professor, Marmara University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2026.26-0220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complications
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainCompletedComplications, PostoperativeUnited States
-
Yale UniversityRecruitingPostoperative Complications (Cardiopulmonary)United States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Wake Forest University Health SciencesTerminatedPerioperative/Postoperative ComplicationsUnited States
-
Technical University of MunichHealth Information Management, BelgiumActive, not recruitingPerioperative/Postoperative Complications
-
Atatürk Chest Diseases and Chest Surgery Training...CompletedPerioperative/Postoperative ComplicationsTurkey
-
Namigar TurgutCompletedPerioperative/Postoperative ComplicationsTurkey
Clinical Trials on Active Heated Humidification
-
ResMedDOM AIRWithdrawn
-
Cliniques universitaires Saint-Luc- Université...Fisher and Paykel Healthcare; AerogenNot yet recruiting
-
Cliniques universitaires Saint-Luc- Université...Fisher and Paykel Healthcare; AerogenNot yet recruitingExcessive Airway SecretionsBelgium
-
Fisher and Paykel HealthcareCompleted
-
Rush University Medical CenterTerminatedRespiratory FailureUnited States
-
Fisher and Paykel HealthcareSleep Disorder Centers Institute for Clinical ResearchCompletedSleep Apnea, ObstructiveUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedChronic Hypercapnic Respiratory FailureItaly
-
Institut für Pneumologie Hagen Ambrock eVResMed GmbH & Co KGCompleted
-
Hospital Sao DomingosUnknownVentilator-associated PneumoniaBrazil