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Completed

NCT Number: NCT06493162

Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation

Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times.

Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred.

For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo elective microscopic laser surgery
  • ASA status I and II

Exclusion criteria

  • Surgery time more than 2 hours
  • Patients with difficult intubation
  • Patients with chronic lung diseases
  • BMI > 25

Treatment and study plan

Intubation

Procedure

Patients will be intubated with 5mm sized endotracheal tube for microscopic laryngeal surgery

flow controlled ventilation

Device

Patients in FCV group will be ventilated with flow controlled ventilation mode

volume controlled ventilation

Device

Patients in VCV group will be ventilated with volume controlled ventilation mode

Primary outcomes

  1. PIP

    Time frame: 10 minutes interval after the intubation during the surgery

    Peak inspiratory pressure

  2. RR

    Time frame: 10 minutes interval after the intubation during the surgery

    Respiratory rate

  3. TV

    Time frame: 10 minutes interval after the intubation during the surgery

    Tidal volume

  4. Compliance (Cdyn)

    Time frame: 10 minutes interval after the intubation during the surgery

    Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)

  5. Resistance

    Time frame: 10 minutes interval after the intubation during the surgery

    Resistance (ventilator calculates: dividing the [peak pressure minus the plateau pressure] by the flowrate in litres per second)

Secondary outcomes

  1. HR

    Time frame: 10 minutes interval after the intubation during the surgery

    Heart rate

  2. MP

    Time frame: 10 minutes interval after the intubation during the surgery

    Mean blood pressure

  3. SpO2

    Time frame: 10 minutes interval after the intubation during the surgery

    Oxygen saturation

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2024
Registry last updated
Feb 27, 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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