Clinical Effects of Intraoperative Heat and Moisture Exchange Systems During Thoracic Surgery: A Prospective Observational Cohort Study

NCT07729319 | Recruiting FDA Device

• 1 other identifier: 09.2026.26-0220
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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).

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; Air Conditioning

Outcome Measures

Primary Outcomes (1)

• 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.

  From completion of surgery through postoperative Day 7.

Secondary Outcomes (11)

• Oxygenation (PaO₂/FiO₂ Ratio)

  Measured during one-lung ventilation and at the end of surgery.

• Frequency of Endotracheal Suctioning

  From induction of anesthesia until completion of surgery.

• Airway Secretion Viscosity Score

  During one-lung ventilation, at the end of one-lung ventilation, and within 24 hours after extubation.

• Incidence of Intraoperative Hypothermia

  From induction of anesthesia until completion of surgery.

• Incidence of Postoperative Hypothermia

  Within the first 24 hours after surgery.

Study Arms (2)

Active Heated Humidification (AHH)

Patients receiving active heated respiratory gas humidification during intraoperative mechanical ventilation according to routine clinical practice.

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.

Device: Heat and Moisture Exchanger

Interventions

Active Heated Humidification DEVICE

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.

Active Heated Humidification (AHH)

Heat and Moisture Exchanger DEVICE

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.

Heat and Moisture Exchanger (HME)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective video-assisted thoracoscopic lung resection requiring one-lung ventilation at Marmara University Pendik Training and Research Hospital.

You may qualify if:

• Patients aged 18 to 75 years
• Elective video-assisted thoracoscopic surgery (VATS)
• Lung resection requiring general anesthesia
• Planned one-lung ventilation
• Written informed consent

You may not qualify if:

• Emergency surgery
• Pregnancy
• Preoperative mechanical ventilation
• Previous enrollment
• Refusal to participate

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Istanbul, 34722, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nezaket Nur Arslan Kömür, MD

  Marmara University

  STUDY CHAIR

• Seniyye Ülgen Zengin, Associate Professor

  Marmara University

  PRINCIPAL INVESTIGATOR

• Meliha Orhon Ergün, Associate Professor, MD

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Nezaket Nur Arslan Kömür, MD

CONTACT

+905392911654; nnurarslan@gmail.com

Seniyye Ülgen Zengin, Associate Professor, MD

CONTACT

+905057142443; ulgen_t@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)