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Completed

NCT Number: NCT07639398

Flow-Controlled Versus Volume-Controlled Ventilation During Suspension Laryngoscopy

Suspension laryngoscopy presents significant challenges for airway management due to the need to maintain adequate ventilation while providing optimal surgical exposure. Flow-controlled ventilation (FCV) is a novel ventilation mode that delivers constant inspiratory and expiratory flow using a narrow-lumen, cuffed endotracheal tube, potentially improving ventilation efficiency in shared-airway surgeries.

This prospective observational study aims to compare flow-controlled ventilation and conventional volume-controlled ventilation in patients undergoing elective suspension laryngoscopy. Respiratory mechanics, hemodynamic parameters, perioperative pulmonary function, and procedure-related complications will be evaluated to assess the feasibility and clinical performance of FCV in this surgical setting.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Training and Research Hospital

Ankara, 06530, Turkey (Türkiye)

About this study

Suspension laryngoscopy is a shared-airway surgical procedure that requires optimal visualization of the operative field while maintaining adequate ventilation and oxygenation. Conventional ventilation strategies may be associated with increased airway pressures and limited surgical exposure due to the use of standard endotracheal tubes. Flow-controlled ventilation (FCV) is a ventilation mode characterized by constant inspiratory and expiratory flow, which may offer advantages in procedures requiring a narrow airway device.

This prospective, non-randomized, observational comparative study evaluates adult patients undergoing elective suspension laryngoscopy. The choice of ventilation strategy-flow-controlled ventilation or conventional volume-controlled ventilation-was based on the attending anesthesiologist's clinical preference, reflecting routine clinical practice. All patients provided written informed consent prior to participation.

In both groups, standardized anesthetic management was applied, and ventilation parameters were adjusted to maintain normocapnia and adequate oxygenation. Intraoperative respiratory mechanics, including airway pressures and lung compliance, were recorded at predefined intervals. Hemodynamic parameters were monitored throughout the procedure. Pulmonary function tests were performed preoperatively and postoperatively using a portable spirometry device. Perioperative complications were documented.

The primary objective of this study is to compare intraoperative respiratory mechanics between flow-controlled and volume-controlled ventilation during suspension laryngoscopy. Secondary objectives include the assessment of perioperative hemodynamic parameters, changes in pulmonary function, and procedure-related complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- Adult patients aged 18 to 65 years

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective suspension laryngoscopy under general anesthesia
  • Body mass index between 18 and 40 kg/m²
  • Provision of written informed consent

Exclusion criteria

- Severe cardiac, pulmonary, hepatic, or renal disease

  • Inability to cooperate with pulmonary function testing
  • Intraoperative hemodynamic instability or oxygen desaturation (SpO₂ <92%)
  • Requirement for tracheostomy during the procedure

Treatment and study plan

Primary outcomes

  1. Peak airway pressure

    Time frame: During surgery with 10 minute intervals

    Intraoperative peak airway pressure (cmH2O) measured at predefined time intervals during suspension laryngoscopy.

Secondary outcomes

  1. Respiratory system compliance

    Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals.

    Respiratory system compliance (mL/cmH2O) measured at predefined intraoperative time intervals.

  2. End tidal carbondioxide

    Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals

    End-tidal carbon dioxide levels (mmHg) measured during suspension laryngoscopy.

  3. Peripheral oxygen saturation

    Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals.

    Peripheral oxygen saturation (%) measured during suspension laryngoscopy.

  4. Forced expiratory volume in one second

    Time frame: 30 minutes before surgery and 12 hours after surgery

    Preoperative and postoperative forced expiratory volume in one second (liter) measured using pulmonary function testing.

  5. Forced vital capacity

    Time frame: 30 minutes before surgery and 12 hours after surgery

    Preoperative and postoperative forced vital capacity (liter) measured using pulmonary function testing.

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Official study title

Comparison of Flow-Controlled Ventilation and Volume-Controlled Ventilation on Respiratory Mechanics During Suspension Laryngoscopy: A Prospective Observational Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2026
Registry last updated
Jun 10, 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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