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NCT Number: NCT07430124

Flow-Controlled Versus Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy

This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on airway pressures and oxygenation in adult patients undergoing balloon dilatation under direct laryngoscopy. Airway procedures performed under general anesthesia are associated with unique respiratory mechanics and limited ventilation conditions, making the choice of an optimal ventilation strategy particularly important.

Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be allocated to receive either FCV or VCV during surgery. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points. The primary outcome is the PaO₂ measured 20 minutes under an FiO₂ of 0.8-1.0 after starting the ventilation under general anesthesia, reflecting early intraoperative oxygenation under stable conditions.

By providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies in patients undergoing balloon dilatation under direct laryngoscopy.

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Key information

Conditions

Airway Stenosis Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Upper Airway Obstruction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 65 years
  • ASA physical status I-III

Exclusion criteria

  • Age < 18 years or > 65 years
  • Known or previously diagnosed pulmonary disease
  • Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ < 50% predicted, severe restrictive or obstructive pathology)
  • Patients with markedly altered lung anatomy or function due to prior major thoracic surgery
  • Patients who were dependent on supplemental oxygen therapy in the preoperative period
  • ASA physical status IV or higher
  • Refusal or inability to provide informed consent

Treatment and study plan

FCV Group

Procedure

Patients allocated to the FCV group will receive mechanical ventilation using a flow-controlled ventilation mode throughout the surgical procedure performed under general anesthesia. Ventilation will be managed according to routine clinical practice, with standardized anesthetic induction and monitoring. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group aims to evaluate the effects of FCV on airway pressures and early intraoperative oxygenation during balloon dilatation performed under direct laryngoscopy.

VCV Group

Procedure

Patients allocated to the VCV group will receive mechanical ventilation using a conventional volume-controlled ventilation mode throughout the surgical procedure under general anesthesia. Anesthetic management and monitoring will follow standard clinical protocols identical to those applied in the FCV group. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas measurements will be recorded at the same predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group serves as the comparator arm to assess the effects of volume-controlled ventilation on airway pressures and oxygenation during balloon dilatation under direct laryngoscopy.

Primary outcomes

  1. The PaO₂ measured 20 minutes after intubation.

    Time frame: 20 minutes after intubation in the intraoperative period

    The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after intubation.

Secondary outcomes

  1. The PaO₂ measured during perioperative period

    Time frame: At the initiation of mechanical ventilation following intubation and at the first postoperative hour after extubation

    The PaO₂ values will be measured and recorded using arterial blood gas analysis.

  2. Peak airway pressure (Ppeak) values during perioperative period.

    Time frame: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation

    Ppeak will be measured and recorded.

  3. Plateau airway pressure (Pplateau) values during perioperative period

    Time frame: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation

    Pplateau will be measured and recorded.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 25, 2026

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.

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