Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation

NCT ID: NCT06493162

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Vocal Cord Disease; Vocal Cord Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

FCV Group

Patients who will be ventilated with flow controlled ventilation following the intubation

Group Type: ACTIVE_COMPARATOR

Intubation

Intervention Type: PROCEDURE

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

Flow Controlled Ventilation

Intervention Type: DEVICE

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

VCV Group

Patients who will be ventilated with volume controlled ventilation following the intubation

Group Type: ACTIVE_COMPARATOR

Intubation

Intervention Type: PROCEDURE

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

Volume Controlled Ventilation

Intervention Type: DEVICE

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

Interventions

Intubation

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

Intervention Type: PROCEDURE

Flow Controlled Ventilation

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

Intervention Type: DEVICE

Volume Controlled Ventilation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Hadi Ufuk Yörükoğlu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hadi Ufuk Yörükoğlu

Role: CONTACT

ufukyorukoglu@gmail.com

+902623038248

Facility Contacts

Hadi Ufuk Yörükoğlu, MD

Role: primary

ufukyorukoglu@gmail.com

+905372439215

Other Identifiers

KAEK/05.bI.07

Identifier Type: -

Identifier Source: org_study_id