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NCT Number: NCT06956079

Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation

" Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. However, OLV increases intrapulmonary shunt due to continued perfusion of the non-ventilated lung, potentially leading to hypoxemia and hypercapnia.

When performed in the supine position, gas exchange becomes more challenging compared to lateral decubitus due to limited gravitational redistribution of blood flow. Although CO₂ insufflation aids surgical exposure through passive lung deflation, it may also increase CVP and PCWP, reduce cardiac output, and raise PaCO₂, contributing to respiratory acidosis.

End-inspiratory pause (EIP), a ventilatory setting that pauses airflow at end-inspiration, prolongs alveolar gas exchange and improves ventilation-perfusion matching. Prior studies show EIP can enhance gas exchange, reduce microatelectasis, and improve CO₂ clearance in patients with acute lung injury. We therefore aimed to assess the effect of EIP application during VATS mediastinal mass excicion.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 20 to 80 years scheduled for video-assisted thoracoscopic mediastinal tumor resection.
  • American Society of Anesthesiologists (ASA) physical status classification of II (patients with mild systemic disease) or III (patients with severe systemic disease limiting activity).

Exclusion criteria

  • Moderate to severe chronic obstructive pulmonary disease (COPD) according to GOLD criteria: defined as FEV₁/FVC < 0.7 and FEV₁ ≤ 80% of predicted on pulmonary function testing.
  • Diffusion capacity of the lung for carbon monoxide (DLCO) < 80% of predicted.
  • History of pneumothorax or presence of bullae or blebs on preoperative imaging.
  • Inability to read or understand the subject information sheet and consent form.

Treatment and study plan

EIP-first

Procedure

EIP is applied for 20 minutes immediately after the initiation of one-lung ventilation, followed by conventional mechanical ventilation.

EIP-later

Procedure

Conventional mechanical ventilation is applied for 20 minutes after the initiation of one-lung ventilation, followed by EIP application.

Primary outcomes

  1. PaCO₂ at 20 minutes after each ventilation method

    Time frame: PaCO₂ is assessed at 20 minutes after each ventilation method

    The study aimed to evaluate whether the application of EIP resulted in a significant intergroup difference in PaCO₂.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.