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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 25, 2026 (before its estimated August 7, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Feb 20, 2026 to Feb 24, 2026
    • Interventions: Flow-Controlled Ventilation (FCV) Group (Procedure), Volume-Controlled Ventilation (VCV) Group (Procedure) to FCV Group (Procedure), VCV Group (Procedure)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07430124
Lead Sponsor Ankara Etlik City Hospital
Conditions
(from sponsor)		 Airway Stenosis, Upper Airway Obstruction
Related terms Airway Obstruction
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov