Flow-Controlled Versus Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years
ASA physical status I-III
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
FCV Group
Procedure/SurgeryPatients 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/SurgeryPatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: FCV GroupActive comparator 1 intervention
Group B: VCV GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The PaO₂ measured 20 minutes after intubation.
The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after intubation.
Time frame
20 minutes after intubation in the intraoperative periodSecondary outcomes
1
The PaO₂ measured during perioperative period
The PaO₂ values will be measured and recorded using arterial blood gas analysis.
Time frame
At the initiation of mechanical ventilation following intubation and at the first postoperative hour after extubation2
Peak airway pressure (Ppeak) values during perioperative period.
Ppeak will be measured and recorded.
Time frame
At the initiation of mechanical ventilation following intubation and 20 minutes after intubation3
Plateau airway pressure (Pplateau) values during perioperative period
Pplateau will be measured and recorded.
Time frame
At the initiation of mechanical ventilation following intubation and 20 minutes after intubationSponsors and contacts
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Source ClinicalTrials.gov